Status:
COMPLETED
Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM
Lead Sponsor:
University of Rochester
Conditions:
Diabetes Mellitus, Type 2
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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 with or without mealtime bolus insulin with no change to total of basal insulin and nutritional baseline insulin dosing \> 10% in the 1 month prior to consent and no changes to non-insulin antihyperglycemic medications in the 3 months prior to consent
- If on a GLP-1 analog, on a stable dose for at least 3 months prior to the study enrollment
- If on an SGLT2 inhibitor, on a stable dose for at least 3 months prior to the study enrollment
- BMI of 27 kg/m2 or greater
- Most recent HbA1c (within 6 months prior to consent) between 6.5% and 9.5%
- Fluent in the English language (education about each diet will be in English)
- Willingness and ability to participate in study protocol.
- Agreeable to give informed consent.
Exclusion
- Diagnosis of T1DM or type 1.5 diabetes mellitus
- 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 an insulin pump or expected to start during the study period
- Use of warfarin (Coumadin)
- Use of daily aspirin 500 mg or more or expected to start during the study period
- Use of daily Vitamin C of 1,000 mg or more, unless willing to stop taking 1 week prior to baseline visit and for duration of study
- Use of antipsychotics or systemic steroids within 3 months prior to consent
- Use of any of the following weight-lowering pharmacotherapy within 3 months prior to consent: phentermine, orlistat, lorcaserin, phentermine/topiramate, bupropion/naloxone
- The use of insulin secretagogues including sulfonylureas 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
- 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 drinks per week in men and more than 3 drinks on any day or 7 drinks per week in women).
- Individuals who are pregnant or breastfeeding 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 uncontrolled symptomatic inflammatory bowel disease, or bariatric surgery in the past 1 year
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04048642
Start Date
December 1 2020
End Date
February 10 2022
Last Update
March 25 2022
Active Locations (1)
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1
UR Medicine/Highland Hospital Nutrition in Medicine Research Center
Webster, New York, United States, 14580