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

NCT04048642 | Completed

• 1 other identifier: STUDY00003764
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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-term changes in insulin requirements and changes in various biomarkers.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Obesity; Nutritional and Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• Change in total daily insulin requirements

  7 Days

Secondary Outcomes (11)

• Changes in glucose excursion curve

  7 days

• Changes in serum leptin

  7 days

• Changes in serum adiponectin

  7 days

• Changes in serum C-peptide levels

  7 days

• Changes in serum insulin levels

  7 days

Study Arms (1)

DASH diet; plant-based diet; DASH diet

EXPERIMENTAL

Food is provided: 7 days of an ad libitum DASH diet, followed immediately by 7 days of an ad libitum whole food, plant based diet, followed immediately by 7 days of an ad libitum DASH diet again.

Behavioral: DASH; Behavioral: Whole-Food, Plant-Based

Interventions

DASH BEHAVIORAL

7 days of a DASH diet

DASH diet; plant-based diet; DASH diet

Whole-Food, Plant-Based BEHAVIORAL

7 days of a WFPB diet

DASH diet; plant-based diet; DASH diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

UR Medicine/Highland Hospital Nutrition in Medicine Research Center

Webster, New York, 14580, United States

Location

Related Publications (1)

• Campbell EK, Taillie L, Blanchard LM, Wixom N, Harrington DK, Peterson DR, Wittlin SD, Campbell TM. Post hoc analysis of food costs associated with Dietary Approaches to Stop Hypertension diet, whole food, plant-based diet, and typical baseline diet of individuals with insulin-treated type 2 diabetes mellitus in a nonrandomized crossover trial with meals provided. Am J Clin Nutr. 2024 Mar;119(3):769-778. doi: 10.1016/j.ajcnut.2023.12.023. Epub 2023 Dec 30.

  PMID: 38160802 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonven Attia, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Thomas M Campbell, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: December 1, 2020
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)