Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM.

  • STATUS
    Recruiting
  • End date
    Dec 2, 2021
  • participants needed
    14
  • sponsor
    University of Rochester
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Updated on 2 February 2021
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Summary

This is a crossover study utilizing a Dietary Approaches to Stop Hypertension (DASH) diet and a whole-food, plant-based diet among subjects with type 2 diabetes who require insulin. Outcomes are short-term changes in insulin requirements and changes in various biomarkers.

Description

This is a single center, prospective, non-randomized crossover study. The aim of the study is to perform a comprehensive evaluation of factors that may contribute to improvements in glycemic control in obese patients with type 2 diabetes during a plant-based dietary intervention. The primary end point will be the change in total daily insulin requirements during the plant-based dietary intervention period compared against a Dietary Approaches to Stop Hypertension (DASH) diet. Evaluation of insulin requirements will be carried out in three phases of this study: pre-intervention (Phase 1), intervention (Phase 2), and post-intervention (Phase 3). Each phase is 7 days. In addition, investigators plan to evaluate the effects of a plant-based diet on glucose homeostasis by estimating the insulin sensitivity index and beta cell function using weekly sampled oral glucose tolerance tests (oGTT) and will explore if these effects correlate with changes in urinary glucose excretion by using weekly sampled urinary tests. Investigators will also be assessing changes in obesity-related inflammatory biomarkers, stress biomarkers and metabolic markers during the three phases of the study. Lastly, given the current technological advantages in the field of diabetes monitoring, investigators plan to monitor the glycemic excursion curve using a continuous glucose monitor during the complete study.

Details
Condition NIDDM, Insulin Resistance, adiposity, Obesity, Diabetes Mellitus, Type 2, Nutritional and Metabolic Disease, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment DASH, Whole-Food, Plant-Based
Clinical Study IdentifierNCT04048642
SponsorUniversity of Rochester
Last Modified on2 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: type ii diabetes or type 2 diabetes or NIDDM or diabetes type 2 or adiposity or Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or Nutritional a...?
Do you have any of these conditions: type ii diabetes or diabetes type 2 or Insulin Resistance or NIDDM or noninsulin-dependent diabetes mellitus or type 2 diabetes mellitus or Diabetes M...?
Do you have any of these conditions: type ii diabetes or Diabetes Mellitus Type 2 or Nutritional and Metabolic Disease or NIDDM or noninsulin-dependent diabetes mellitus or Obesity or Dia...?
Adults (older than 18 years old) of both genders, of all races and ethnicities
Pre-existing diagnosis of Type 2 diabetes mellitus, as documented in medical records, on basal insulin with or without mealtime bolus insulin and no changes in antihyperglycemic medications in the past 3 months; Patient's on sulfonylureas, glinides and SGLT2 inhibitors will not be included in the study
Adult's on stable dose of GLP-1 analogs for at least 6 months prior to the study enrollment
BMI of 27 kg/m2 or greater
Most recent HbA1c between 6.5% to 9.5%
Fluent in the English language as education about each diet will be in English
Willingness and ability to participate in study protocol
Agreeable to give informed consent

Exclusion Criteria

HbA1c less than 6.5 % or greater than 9.5% within 3 months prior to the study consent
BMI less than 27 kg/m2
Diagnosis of T1DM
History of liver cirrhosis
Impaired renal function (GFR < 45 ml/min) within 6 months prior to consent
History of hyperkalemia (potassium > 5.4 meq/L) within 6 months prior to consent
Use of daily aspirin greater than 500 mg or expected to start during the study period
Use of daily Vitamin C greater than 1,000 mg or expected to start during the study period
Use of antipsychotics or systemic steroids within 3 months prior to consent
Use of weight-lowering pharmacotherapy (phentermine, orlistat, lorcaserin, phentermine/topiramate, bupropion/naloxone) within 3 months prior to consent
The use of insulin secretagogues including sulfonylureas, GLP-1 analogs, and glinides within 3 months prior to consent as this may increase the risk of hypoglycemia and alter assessment of daily insulin requirements during the study
Use of any SGLT2 inhibitors within 3 months prior to consent as this will alter analysis of urinary glucose levels, hence it's mechanism of action as it cause's glucosuria
The use of illicit drugs, defined as active use or use within 3 months prior to consent
Engage in high risk alcohol use (defined as more than 4 drinks on any day or more than 14 per week in men and more than 3 drinks on any day or 7 per week in women)
Individuals who are pregnant or intend to become pregnant during the duration of the study
Individuals who are following a vegetarian or vegan diet at the time of consent
Food allergies or intolerances that will interfere with diet adherence
Lack of access to a full size refrigerator (required for storage of 3-4 days of prepared study meals)
Active malabsorption disorder, including inflammatory bowel disease, or history of bariatric surgery
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