Phase
Condition
Hypertriglyceridemia
Obesity
Diabetes Prevention
Treatment
Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)
Dietary Monitoring
Time-Restricted Eating (TRE)
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 18-70 years
BMI ≥ 25 kg/m2
Own a smartphone (Apple iOS or Android OS)
Baseline eating window ≥ 14 h/day
Night shift nurses and nursing assistants who are working a 12-hour night shift atleast 3 days/week.
Have been doing night shift work for at least 3 months.
Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins),metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeastrice and fish oil), anti-hypertensive, drugs), are allowed
If patients have Type 2 Diabetes, they will be included in the study if A1c is lessthan 9 and they are not on insulin.
Exclusion
Exclusion Criteria:
Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days ofbaseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
Use of sulfonylurea or insulin within the last 3 months (due to unknown safety withTRE)
Use of medications that are known to cause weight loss such as SGLT2 inhibitors andGLP1 receptor agonists)
BMI > 50 kg/m2
Change in medications that could impact study outcomes within the past 3 months
Change in weight of >4kg in the past 3 months
Women who are pregnant, breastfeeding, or are trying to become pregnant during thestudy period. If a participant becomes pregnant during the study, they will beexcluded from continuing the study.
Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
Fasting LDL cholesterol greater than 250 mg/dL
Fasting triglycerides greater than 500g/dL
Active tobacco abuse or illicit drug use or history of treatment for alcohol abusein the past 5 years.
Frequent (more than 4) travel involving a time zone change of more than 3 hours overthe 1-year study period
Prolonged leave from work (a continuous month or longer) during the study
Active treatment for inflammatory and/or rheumatologic disease
History of a major adverse cardiovascular event within the past year (acute coronarysyndrome, percutaneous coronary intervention, coronary artery bypass graft surgery,hospitalization for congestive heart failure, stroke/transient ischemic attack)
Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter areacceptable)
History of thyroid disease requiring dose titration of thyroid replacementmedication(s) within the past 3 months (hypothyroidism on a stable dose of thyroidreplacement therapy is allowed).
History of adrenal disease in the past 5 years
History of malignancy undergoing active treatment, except non-melanoma skin cancer,in the past 5 years
History of an eating disorder in the past 5 years
History of cirrhosis in the past 5 years
History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
History of HIV/AIDs
Currently enrolled in weight-loss or weight-management program
Any history of surgical intervention for weight management
Uncontrolled psychiatric disorder including prior hospitalization
Study Design
Study Description
Connect with a study center
University of California San Diego Altman Clinical and Translational Research Institute
La Jolla, California 92037
United StatesSite Not Available
University of California San Diego Altman Clinical and Translational Research Institute
La Jolla 5363943, California 5332921 92037
United StatesActive - Recruiting

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