Time Limited Eating in Adolescents With Type 2 Diabetes

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    40
  • sponsor
    Children's Hospital Los Angeles
Updated on 5 August 2021
diabetes
fasting
metformin
hemoglobin a1c
fats
a 12
sugars

Summary

Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens based on macronutrient composition and kilocalories. Our preliminary data support TLE feasibility, acceptability, and safety in adolescents. However, no trial to date has studied the effects of 8-hour TLE on glycemic control and body composition in adolescents with T2D. Our long-term goal is to improve outcomes for adolescents living with T2D by incorporating meal-timing behaviors as part of their medical regimen early in diagnosis. We hypothesize that TLE (8-hr eating period/16-hr of daily fasting) will minimize glycemic excursions, delay -cell deterioration, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods (12+hours). One-hundred adolescents with T2D (aged 14-21 years), diagnosed within the last 6 months, with a hemoglobin A1c < 9%, and on Metformin monotherapy, will be recruited from Children's Hospital Los Angeles. All participants will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating or (2) TLE. We will test the hypothesis through the following Specific Aims:

Aim 1: Test the effect of TLE on glucose control and -cell function in youth with T2D. We will measure (a) glycemic control with a continuous glucose monitor (CGM) to capture percent time in range (%TIR) and hemoglobin A1c (HbA1c) and (b) -cell function using the insulinogenic index (IGI) after a mixed meal tolerance test (MMTT). We expect TLE to result in greater increase in %TIR and IGI and decrease in HbA1c compared to control.

Aim 2: Test the effect of TLE on obesity and liver fat in youth with T2D. We will measure (a) total body fat by DEXA scan and (b) liver fat fraction by liver MRI during the pre- and postintervention period. We expect TLE to result in a greater decrease in total body fat, and liver fat than the control.

Aim 3: Test the effect of TLE on sleep, physical activity, and dietary intake. We will compare change in sleep, physical activity, and dietary intake between TLE and control. Questionnaires will be given at baseline and post intervention. The data generated will explore how meal timing may influence occurrence, timing, and distribution of sleep and daily movements as well as dietary intake and caloric distribution compared to control.

Description

3.2. Overview of Proposed Study Design: We propose a pilot randomized controlled trial (RCT) testing the efficacy of TLE on glycemic control, -cell function, and body composition among adolescents with T2D. The implementation steps of the proposed RCT are as follows (See Table 3): (1) The staff will introduce the study to all eligible participants either in person or virtually and consent interested families for the study; (2) All participants and their families will complete baseline study surveys in REDcap; (3) All participants and their families will receive training on the use and application of the Dexcom G6 CGM139, which is FDA approved in patients 2 years and older. All equipment required for the duration of the study will be distributed to the participants in-person. Participants will receive enough sensors to wear the CGM daily for the entire study period. Participants will be instructed to change their sensor every 10 days with the assistance of the study staff. Each participant will be asked to download the CGM app onto their personal smartphone and set up an account with a pseudonym. (4) All participants and their families will receive standard nutritional counseling and be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating or (2) TLE (8-hr eating period/16-hr of daily fasting). During the eating window, participants will not be required to count calories or monitor their food intake. Participants will choose and pay for their own food during the intervention. All participants will record their eating window daily and submit it to the study staff via REDcap. All participants will receive standard recommendations for physical activity, screen, and sleep time as per the American Academy of Pediatrics age appropriate recommendations at the first visit140; (5) The study staff will conduct study assessments with participants at week -1, 0, 1, 4, 8, and 12; (6) The study staff will perform weekly phone encounters with the participants to assess barriers to adherence and review the CGM data. If a barrier is identified the study staff will create a solution plan to promote adherence and retention. The study staff will record any medication changes or health issues that have occurred in the last 7 days; (7) To further inform future trials and scalability we will continuously collect recruitment, consent, and retention rates, and barriers to engagement; 9) Adverse Event Monitoring (See Human Subject Protection Plan for full details) will be monitored. If at any time, the study staff notices any unhealthy compensatory behaviors the PI will be notified and a treatment plan will be created to ensure that the participant receive the appropriate screening, work-up, and diagnosis from their primary care provider and are withdrawn from the study if appropriate. (8) The PI and research team will meet bi-weekly to monitor all study procedures and oversee data management and analysis.

Participants: We will recruit 100 adolescents (age 14-21 years at enrollment, all gender expressions) from clinical programs at CHLA. All adolescents newly diagnosed with T2D and referred to the endocrinology clinic at CHLA will be screened. Inclusion criteria are: (1) age 14-21 years; (2) Tanner stage III and above; (3) diagnosis of T2D based on the ADA diagnostic guidelines48; (4) hemoglobin A1c < 9% on Metformin monotherapy (based on the ADA and International Society for Adolescent and Pediatric Diabetes recommendations. At CHLA we currently recommend Metformin Monotherapy for any patients with HbA1c <9% at onset and therefore will use this cut off for the study);25 (5) participant and/or parent/guardian or family member must have a personal smart phone that is CGM compatible; and (6) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods. To limit confounding factors, individuals will be considered ineligible to participate if they meet any of the following exclusion criteria: (1) previous diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity; (2) serious developmental or intellectual disability; (3) previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder); (4) parent/guardian-reported physical, mental of other inability to participate in the assessments (e.g., inability to wear CGM, inability to undergo imaging testing without sedation); (5) previous or planned bariatric surgery; (6) current planned use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, glucagon-like-peptide-1 agonist, naltrexone, buproprion, SGLT-2 Inhibitor, insulin etc.); or (7) current participation in other interventional weight loss studies. A random block stratified randomization scheme will be used. Randomization tables will be first generated using SAS and fed into the study REDCap database. Participants will be randomized 1:1 via stratified, blocked randomization to ensure the groups are balanced in terms of number of participants and distribution of potential confounding variables including sex and age. Block size will be blinded from the PI performing the study.

3.3. Feasibility of recruiting economically, racially, and ethnically diverse participants. The high volume CHLA endocrinology clinic has seen 96 patients with new onset T2D (> 14 to < 21 years old) in the past year. Of those, 50 patients had an HbA1c < 9.0% and would have been eligible for the study. The demographics of our patient population are: mean age 16.9 years, 60% female, mean age of diagnosis 13.2 2.3 years. Sixty-five percent of our patients self-identify as Latinx, compared to 47.5% of the population in Los Angeles.141 At CHLA, we have a long history of conducting investigator-initiated studies in youth with T2D, including large consortium studies such as the Treatment of Diabetes in Adolescents and Youth (TODAY) trial16, SEARCH for diabetes in youth22 and Prevent Diabetes Consortium (PDC). 50 At CHLA, the recruitment rate in this population is between 50-60% with a retention rate of 60-80%. Based on our recruitment history in adolescents with T2D, we anticipate a consent rate of 50-60%, retention rate of 75-80%, and recruitment of 30 adolescents per year to reach our target recruitment of 100 adolescents by year 4.

3.4. Retention strategies. Each participant, regardless of which group they are randomized to, will receive compensation in the form of gift cards. Participants will receive $50 at each study visit they attend (5 visits for a total of $250 per participant). Parents/guardians/family members will also receive $20 gift card for each study visit they attend for a total of $100 for participation in the study to account for time and effort required to support their participant. Parking validation will be provided. All families who do not have a car will be offered free ride-sharing transportation to- and from study visits upon request. To foster treatment adherence, participants will receive weekly calls from the study staff for the duration of the trial. Counseling will be conducted by trained research staff. The sessions will serve three purposes: (1) foster adherence, retention, and accountability; (2) troubleshoot intervention barriers; and (3) monitor safety endpoints. During the sessions, participants will be provided with the support, knowledge, skills, and resources they need to successfully adhere to the protocol. The research staff will analyze the adherence data and progress using multiple-pass methodology. To support participants, the staff will use behavioral techniques, such as stimulus control, goal setting, behavioral contracting, and motivational interviewing. In addition, the staff will assist participants in troubleshooting any adherence issues and give participants additional encouragement and support when adherence problems arise. If a participant adheres to meal timing protocol < 4 days/week, a follow-up call or videoconference will be scheduled to address challenges and to counsel participants. Furthermore, In order to reduce participant burden, if at all possible study procedures will be scheduled to coincide with participants' scheduled clinical visits.

3.5. Intervention Arms: Dietary counseling (all participants): All participants will attend the new onset T2D education curriculum delivered at CHLA. The dietary counseling is modelled after the Healthy Eating through Reduction of Excess Sugar (HEROES) intervention (NIH R01 MD010358-A1), which is currently used by Dr. Michael Goran's team at CHLA as a method to reduce added sugar intake in diets for youth with obesity and fatty liver disease. The intervention consists of recommendations for low added sugar and a moderate carbohydrate-controlled daily diet. No specific caloric restriction will be recommended, and participants will not be required to keep logs of daily consumption.

Time-Limited Eating (TLE): The TLE intervention arm will involve instructing participants to only eat from 11 AM to 7 PM. We conducted a cross sectional analysis of a cohort of 100 adolescents with obesity and found that most total calories, carbohydrates, and added sugars were consumed between 11 AM and 7 PM.42 Therefore, to align with the normal developmental eating patterns seen in adolescents, we will implement an afternoon TLE approach. Participants will be allowed to consume non-caloric beverages (water, tea, coffee) during the fasting period. No energy restriction will be required. All participants will be asked to record their eating times daily and submit to the study team via REDcap.

Control: The control arm will have no mealtime restrictions on eating. Participants will be instructed to consume food over a 12-hour or more eating window without mealtime schedule. No energy restriction will be required. All participants will be asked to record their eating windows daily and submit to the study staff via REDcap.

Exercise: No structured exercise intervention will be included. However, regular physical activity is encouraged, consistent with the guidelines for T2D management in youth.142 Participants will complete a Physical Activity Questionnaire over the study period to monitor the impact of TLE on physical activity.

3.6. Measurements: The study team will conduct all assessments at week -1, 0, 4, 8 and 12. All data will be collected and stored in REDCap.

Aim 1: Test the effect of TLE on glucose control and -cell function in youth with T2D. We will measure (a) glycemic control by using a continuous glucose monitor (CGM) to capture percent time in range (%TIR) and hemoglobin A1c (HbA1c) and (b) -cell function using the insulinogenic index (IGI) after a mixed meal tolerance test (MMTT).

Quantifying glycemic control (%TIR): Using a Dexcom G6 CGM, FDA approved in patients 2 years and older, we will capture glucose readings every 5 minutes and obtain the weekly %TIR (defined as glucose levels from 70 mg/dL to 180 mg/dL142) over the course of the study. CGM provides robust data about change in glycemic control in response to an intervention by capturing frequent glucose trends throughout the day in response to all daily activities. and has been shown to have a good correlation with HbA1c measures.143 Vigersky et al. demonstrated that a 10% change in the %TIR is equivalent to a 0.8% change in HbA1c. 143 Hemoglobin A1c: HbA1c will be collected via venous blood draw at the CHLA laboratory at week 1 and 12. HbA1c will be measured using a DCA 2000 (Bayer Corporation, Elkhart, IN) and compared pre- and post- intervention between TLE and control.

Quantifying change in -cell function: Change in IGI after MMTT: The MMTT provides a simultaneous estimate of insulin secretion and sensitivity.143-148 To improve participant burden and decrease project cost, the modified MMTT will be utilized. Previous adult TLE trials have utilized the IGI as a surrogate marker of -cell function in TLE trials.66 Therefore, we will evaluate the effect of TLE on changes in IGI measured after MMTT. The MMTT will be performed at weeks 0 and 12. Participants will be instructed to not take their Metformin for 48 hours prior to their MMTT. Following baseline sampling (0 min), a test meal (470 kcal, 66% carbohydrate, 18% fat, and 16% protein) composed of one 8-fluid-ounce Boost nutrition supplement drink (Nestl Health Science) and one Power Bar (Nestl Nutrition) will be administered. The meal will be consumed within 10 min and repeat sampling will be performed at 0, 30, 60-, 90- and 120- minutes post-meal for C-peptide, glucose and insulin levels.

Statistical Consideration (For Full Plan See Statistical Analysis Section in Human Subject Research): The sample size estimates, and analytical plans were developed under the guidance of Dr. Ramon Durazo-Arvizu from the Biostatistics core at TSRI. Descriptive statistics, including graphical depictions, will be utilized to assess the degree of symmetry/normality of continuous outcomes and identification of outliers. A ladder of powers approach will be applied to identify the best easy-to-interpret transformation of the outcome variable. Statistical analyses will be implemented with and without transformations in addition to generalized linear mixed models, when appropriate. All regression models will be adjusted for baseline of outcome levels, as this adjustment increases power (reduces required sample size).149,150 A false discovery rate (FDR)151 approach will be applied to assess the effect of multiple testing. An FDR of 10% or higher will be used given the pilot nature of the study. Statistical analyses will be performed using STATA 17.0(STATA Corp, College Station, TX). Graphs will be generated using the R package ggplot2, STATA and PRISM and will include mean, SD or SEM and Confidence interval (CI) for change data. The study is designed to compare the average primary outcomes (%TIR, HbA1c, IGI, and Total Body Fat Mass) over time as well as marker change from baseline (week 0) to end of the study (week 12) between intervention groups (TLE vs. control). Study participant's drop-out in clinical trials is a prevalent problem, which results in missing data. Statistical analyses will be crafted under three different mechanisms, namely missing completely at random (MCAR), missing at random (MAR), and other missing data patterns.152-155 Our first approach to statistical analysis with missing data will follow common practice, such as last value carried forward, and multiple imputations.156-159 Last value carried forward and multiple imputation will be carried out to generate complete data prior to analyzing data under the intention-to-treat principle. A per-protocol analysis will also be performed and compared to results obtained under the intention-to-treat approach. 160 Statistical Considerations: No studies in the literature specifically addressed all our aims. Nevertheless, we were able to extract reasonable effect size information from several intervention-based studies, including some TLE studies conducted in adults.6,8,9,66,161 The primary outcomes for Aim 1 are the difference between TLE and control in: a) average %TIR overtime, b) HbA1c at week 12 compared to baseline, and c) average IGI after MMTT at week 12 compared to baseline.

  1. Percent Time in Range(%TIR): Statistical Analysis Plan. Average %TIR will be extracted from the CGM data for the 7-day period prior to the study visit point and assessed at week 0, 4, 8, and 12. A sequential analysis plan will be executed starting with graphical depictions of %TIR distributions at baseline and 12 weeks followed by model-based approaches that make use of all information collected. This approach facilitates interpretations of study findings. 1) Descriptive statistics, such as means (confidence intervals), histograms, Box plots of %TIR will be constructed by group; 2) A two-sample t-test used to compare average %TIR between TLE and control groups, followed by ANCOVA (multivariable linear regression) to adjust for baseline (week 0) %TIR values and other unbalanced variables; 3) A change variable (%TIR at week 12 minus %TIR at week 0) will be generated for each study participant and average values adjusted for baseline %TIR and confounders compared via multivariable linear regression; 4) The previous analysis techniques do not take full advantage of the repeated measures in each individual. A linear mixed effect model with random intercept (LME) adjusting for baseline and confounding factors will be fit to compare the two treatment arms. Power/Sample Size Justification. No preliminary data was available of the effect of TLE in youth with T2D on %TIR so effect size estimates were drawn from adult data on the impact of nutrition intervention on %TIR and based on a minimum effect size equal to the difference between the two groups divided by the SD (Cohen's d). Extracting from adult data, and data from youth with type 1 diabetes, a change in %TIR of greater than 5% is considered clinically significant, this correlates with an estimated change in HbA1c of -0.4%. Because we targeted improvements in %TIR, a one-sided at a 5% significance level to detect a benefit of TLE compared to control was used for each comparison, with a conservative within-subject correlation of 0.6 (spherical variance-covariance matrix). The required sample size to detect a pre-specified effect size (Cohen's d = difference in means in standard deviation units) of 0.34 with 80% power using an LME models (adjusting for baseline %TIR) with four %TIR determinations at weeks 0, 4, 8 and 12 results in 40 subjects per group (80 total).162 A 20% attrition rate was observed in our preliminary data collected from our pilot study of TLE in adolescents. The attrition-adjusted total sample size is 100 (80/0.8) participants. Furthermore, data extracted from adult studies suggests that the standard deviation of %TIR is between 16 and 25%.143 Thus, a 0.34 effect size and a standard deviation of about 20% (midpoint between 16 and 25) amounts to a difference in %TIR of about 6.8% (0.34*20% = 6.8%). We will seek to decrease attrition using the experienced gained and by following study participants even after treatment discontinuation.
  2. Change in HbA1c: Statistical Analysis Plan. As above a sequential analysis approach will be implemented. Graphical and numerical depictions of data by intervention arm first, followed by a two-sample, one sided, 5%-significance t-test (equivalent to simple linear regression) to assess difference in HbA1c from baseline to week 12 between TLE and control. Power/Sample Size Justification. Calculations are based on the latter model. Carter et al. examined the impact of intermittent energy restriction compared to continuous energy restriction in adults with T2D and found that there was a between group difference of -0.2% with an SD of 0.1%.14 On the other hand, Toledo-Corral, et. al., estimate the mean and standard deviation of HbA1c among children aged 8-17 years of about 5.75% and 0.2%, respectively.163 An application of a one-sided, two-sample, 5%-significance t-test with 50 participants per intervention group (40 prior to attrition adjustment) will detect an effect size (mean HbA1c change) of -0.12% with 85% power, assuming a correlation between week 0 and week 12 HbA1c determinations of about 0.6.
  3. Insulinogenic Index after MMTT: Statistical Analysis Plan. To evaluate the difference in -cell function between TLE and control we will measure the difference in IGI change following MMTT at week 12 compared to baseline utilizing a two-sample, one-sided, 5%-significance t-test (special case of simple linear regression). A multivariate linear regression model will be fit to the data to compare mean IGI change adjusting potential confounders (unbalanced baseline variables), including baseline IGI values. Power/Sample Size Justification. A recent pilot study of TLE in an adult cohort without diabetes, showed TLE increased the IGI by 14 7 U/mg compared to control at week 6 compared to baseline.66 A total sample size of 100 participants (80 before adjusting for attrition) will thus detect a difference in IGI change of 4.2 with 85% power using the 5%-significance, one-sided, two-sample t-test. Additional power is gained by adjusting for baseline IGI and unbalanced participant characteristics.

Aim 2: Test the effect of TLE on obesity and liver fat in recently diagnosed youth with T2D. We will measure total body fat by DEXA scan and liver fat fraction by liver MRI-PDFF pre- and post- intervention period.

Quantification of body composition: Total Body Fat: Using a Hologic QDR 5400 densitometer (Hologic, Inc., Bedford, MA) DEXA scan, we will measure the change in TBF at week 12 compared to baseline between TLE and control. Liver Fat Fraction: Change in liver fat will be measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Participants will undergo MRI screening examinations at baseline and week 12 using an advanced magnitude-based spoiled-gradient-echo MRI-PDFF estimation technique previously validated to measure hepatic steatosis in children.164-168 Key MRI-PDFF scanning parameters will be: 3T MRI scanner (GE 3T 750, and Siemens 3T TrioTim), 2D axial spoiled-gradient-echo breath hold acquisitions, TR > 100 ms, six TE values evenly spaced from 1.15 to 6.9 ms, flip angle 10 degrees, number frequency-encoding steps between 140 and 192, number phase-encoding steps between 128 and 140, no filters, no saturation, slice thickness 6 to 10 mm (contiguous), and rectangular field-of-view to accommodate body habitus. 164

Statistical Consideration: Statistical Analysis Plan. We will utilize multivariate linear regression model to adjust for potentially unbalanced variables across group, in particular baseline values. Power/Sample Size Justification. A recent systematic review of the impact of TLE on cardiometabolic outcomes, showed that in adults TLE has variable effect on total body fat mass with some studies showing a decrease of up to 4 kg compared to control and others showing no change in TBF and liver fat fraction compared to control.134,137,169 A previous study estimated the mean and standard deviation of Liver Fat (HFF) among children 18 and younger is about 8 and 8, respectively. A one-sided, two-sample, 5%-significance t-test will detect a difference in liver fat as large as 3.25 with 81% power, adjusting for baseline values, with 50 children per treatment arm.

Aim 3: Test the effect of TLE on sleep, physical activity, and dietary intake. We will compare change in sleep, physical activity, and dietary intake between TLE and control. Questionnaires will be given at baseline and post intervention. The data generated will explore how meal timing may influence occurrence, timing, and distribution of sleep and daily movements as well as dietary intake and caloric distribution compared to control.

Secondary Outcomes: Nutrient Data System Recall (NDSR) 24 Hour Dietary Recall45: Twenty-four-hour dietary recalls will be conducted for all participants pre- and post-intervention. One weekday and one weekend day will be collected for all participants. International Physical Activity Questionnaire (IPAQ)170-175: The International Physical Activity Questionnaire (IPAQ) has been developed to estimate levels of habitual physical activity across different countries and socio-cultural environments and will be collected at 5 time points.6 Munich Chronotype Questionnaire for children and adolescents (MTCQ)176,177: The Munich ChronoType Questionnaire (MCTQ) is a self-rated scale to assess sleep structure, patterns, duration, and quality and will be collected at 5 time points.

Statistical Consideration: Statistical Analysis Plan. All outcome variables (sleep, physical activity, and dietary intake) will be treated as continuous. The ladder of transformations approach156,157will be implemented to improve symmetry and/or approximate normality of their distribution. The analysis will follow the sequential approach suggested for Aims 1 and 2. We will take advantage of the within-person correlation (assumed to be about 0.6) to improve efficiency of variance estimators. Furthermore, all comparisons between the TLE and control arms will control for baseline values. Should randomization be imperfect for some variables, the multivariate regression model will be adjusted. The study was not powered to assess mediation or moderation of each secondary outcome; however, we will estimate direct and indirect effects of the interaction between the outcomes. Power/Sample Size Justification. Given the estimated sample size, and desired statistical power, the minimal effect size (Cohen's d) is estimated, under the assumption of 0.6 correlation of each of the outcome variables between baseline (week 0) and follow-up (week 12). A 5%-significance, one-sided, two-sample t-test with the operating characteristics describe above will detect an effect size as large as 0.5 (mean difference in standard deviation units). As an alternative to hypothesis testing, we will determine 95% confidence intervals in response to the interventions that will provide evidence worthy of further investigation in adolescents with T2D. Additional Considerations: Many authors have argued that the use of "significance testing" of hypothesis does not fully address the scientific research questions. Instead, the use of confidence intervals has been advocated for the assessment these questions.178-181 Confidence intervals not only allow for a better interpretation of effect estimates and their variability but could also be used to discriminate between group differences. Although results from this study will be evaluated using traditional techniques, such as p-values, we will rely on interpretation via confidence intervals. As a result, parameter estimates (e.g., mean difference, change and trends) will be used to aid scientific reasoning.178 Potential Challenges and Alternative Approaches: 1) Recruitment: The CHLA T2D cohort is predominantly Latinx. We considered using a recruitment strategy to ensure balanced proportion of ethnic groups. However, given the population of Los Angeles in general and those served at CHLA, we opted to recruit all interested participants who met eligibility criteria. This approach will provide the opportunity to conduct our research with minority populations and improve my cross-cultural sensitivity and research approach; 2) Study Design: a) We considered including a group not on Metformin; however, robust literature exists that describes the natural trajectory of T2D disease progression in untreated adolescents.52,56,57,59-62,74,182 Therefore, it did not appear ethically appropriate. b) We considered a more robust crossover design. However, given the behavioral components of the approach, we believed there was a high risk of contamination and bias that would be unable to be separated appropriately between TLE and control. c) Ensuring difference in eating windows between groups. We acknowledge that habitual eating windows for adolescents may be intrinsically condensed due to shifting chronobiology leading to staying up late and waking up late.42 To overcome this, we will request the control group consume their meals over a 12+hour period and have all participants report their eating windows to confirm the between group difference. 3) Assessment: -cell function: The hyperglycemic clamp and FSIGT have been the most widely reported and acceptable methods to evaluate -cell function. However, given this is a limited resources proposal in adolescents, we elected to utilize the modified MMTT procedure, which is both more cost- effective and tolerable for pediatric participants.

Details
Condition NIDDM, Diabetes Mellitus, Obesity, Childhood Obesity, Pediatric Obesity, type 2 diabetes mellitus, obesity in children, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Control, Continuous Glucose Monitor, Time Limited Eating
Clinical Study IdentifierNCT04536480
SponsorChildren's Hospital Los Angeles
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(1) age 14-21 years
(2) Tanner stage III and above; (3) diagnosis of T2D based on the ADA
diagnostic guidelines; (4) hemoglobin A1c < 9% on Metformin monotherapy (based
on the ADA and International Society for Adolescent and Pediatric Diabetes
recommendations. At CHLA we currently recommend Metformin Monotherapy for any
patients with HbA1c <9% at onset and therefore will use this cut off for the
study);25 (5) participant and/or parent/guardian or family member must have a
personal smart phone that is CGM compatible; and (6) participant must be
willing and able to adhere to the assessments, visit schedules, and
eating/fasting periods. To limit confounding factors, individuals will be
considered ineligible to participate if they meet any of the following

Exclusion Criteria

(1) previous diagnosis of Prader-Willi Syndrome, brain
tumor or hypothalamic obesity; (2) serious developmental or intellectual
disability; (3) previous diagnosis or subthreshold symptoms of an eating
disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder); (4)
parent/guardian-reported physical, mental of other inability to participate in
the assessments (e.g., inability to wear CGM, inability to undergo imaging
testing without sedation); (5) previous or planned bariatric surgery; (6)
current planned use of an anti-obesity or other diabetes medication (e.g
phentermine, topiramate, orlistat, glucagon-like-peptide-1 agonist
naltrexone, buproprion, SGLT-2 Inhibitor, insulin etc.); or (7) current
participation in other interventional weight loss studies
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