An interventional study of Dietary intervention in Diabetes Mellitus, Type 2, sponsored by Physicians Committee for Responsible Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on changes in intramyocellular and hepatocellular lipid content in adults with type 2 diabetes. Changes in insulin sensitivity and glycemic control will also be assessed in this study. The study duration is 44 weeks.
Type 2 diabetes is a disease characterized by discordance between the amount of insulin produced by pancreatic β-cells and the amount of insulin required to overcome insulin resistance in the liver and peripheral tissues. The development of insulin resistance has been strongly associated with the prolonged accumulation of lipids (fats) in the liver cells ("hepatocellular lipid") and muscle cells ("intramyocellular lipid"). Conventional pharmacologic therapeutics for type 2 diabetes, like metformin, are designed to reduce the accumulation of hepatocellular and intramyocellular lipids and, thereby, augment insulin sensitivity. Research has shown that a low-fat, plant-based diet, in which the consumption of lipids is limited, is a similarly effective therapeutic intervention for the reduction of hepatocellular and intramyocellular lipid content and the improvement of insulin sensitivity in type 2 diabetes.
The purpose of this study is to compare the effects of low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on hepatocellular and intramyocellular lipid content in adults with type 2 diabetes. Using a cross-over design, participants with type 2 diabetes will be randomly assigned to start with a plant-based or a portion-controlled diet for 22 weeks. The two groups will then switch to the opposite diet regimen for an additional 22 weeks. Before and after each intervention period, the investigators will measure intramuscular and liver fat content. The investigators will also assess the relationship between these variables, insulin sensitivity, and glycemic control.
The investigators hypothesize that both dietary interventions will result in reductions in intramuscular and liver fat content, and that these changes will be associated with improvements in insulin sensitivity and glycemic control in individuals with type 2 diabetes. The investigators further hypothesize that the low-fat, plant-based dietary intervention will elicit greater changes in intracellular lipid concentration, compared with the portion-controlled dietary intervention.
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Exclusion criteria are as follows:
Participants will also review and complete the Yale MRI Safety Questionnaire to determine eligibility for the study.
For a 22-week period, participants will be asked to follow a low-fat vegan diet which consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. In choosing grain products and starchy vegetables (e.g., bread, potatoes), participants will be encouraged to select those retaining their natural fiber and having a glycemic index \<70, using tables standardized to a value of 100 for glucose.
Behavioral: Dietary intervention
For a 22-week period, participants will be asked to follow a portion-controlled diet which will include individualized diet plans that reduce daily energy intake by 500 kcal for overweight participants, and keep carbohydrate intake reasonably stable over time. It will derive 50% of total energy from carbohydrates, 20% from protein, and less than 30% from fat (≤7% saturated fat), with less than 200 mg/day of cholesterol/day.
Behavioral: Dietary intervention
Low-fat, plant-based diet and a portion-controlled diet
Intramyocellular lipid content
Proton magnetic resonance (MR) spectroscopy at 4T (Bruker) will be implemented to quantify intramyocellular lipid concentrations.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Hepatocellular lipid content
Proton magnetic resonance (MR) spectroscopy at 4T (Bruker) will be implemented to quantify intramyocellular lipid concentrations.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Insulin sensitivity
Insulin resistance will be assessed by the Homeostatic Model Assessment (HOMA) PREDIM indexes
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Concentration of glucose
Concentration of glucose will be assessed during a standard meal test (Boost Plus, Nestle, Vevey, Switzerland; 720 kcal, 34% of energy from fat, 16% protein, 50% carbohydrate). Plasma concentrations of glucose will be measured at 0, 30, 60, 120, and 180 min.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Concentration of C-peptide
Concentration of C-peptide be assessed during a standard meal test (Boost Plus, Nestle, Vevey, Switzerland; 720 kcal, 34% of energy from fat, 16% protein, 50% carbohydrate). Concentration of C-peptide will be measured at 0, 30, 60, 120, and 180 min.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Rate of glycemic control
Rate of glycemic control will be assessed through HbA1C.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Resting energy expenditure
Resting energy expenditure REE (pulse, respiratory rate and body temperature) will be measured for 20 minutes through indirect calorimetry utilizing a ventilated hood system in fasting participants.
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Postprandial metabolism
Postprandial metabolism will be measured by indirect calorimetry. Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Following 30 minutes of quiet rest in a dimly lit room, pulse, respiratory rate, and body temperature will be measured. Resting energy expenditure will be measured for 20 minutes through indirect calorimetry utilizing a ventilated hood system. Postprandial metabolism will be measured four times, 20 minutes each time, over the course of 3 hours after the standard breakfast.
Time frame: Change from Baseline to 22 weeks and change from 22 weeks to 44 weeks
Body Composition
Body composition will be measured by dual energy x-ray absorptiometry (Lunar iDXA, GE Healthcare; Madison WI), assessing visceral adipose tissue volume and mass.
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Gut microbiome composition
Quantitative determination of microorganisms and global analysis of microbial diversity from stool sample. The mean of the change between time points in bacteria counts.
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Concentration of plasma lipids
Change in plasma cholesterol \& triglycerides.
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Body weight
Change in body weight measured on a calibrated scale.
Time frame: Change from baseline to 22 weeks and change from 22 weeks to 44 weeks
Advanced Glycation Endproducts (AGEs)
Advanced Glycation Endproducts (AGEs) will be measured using the AGE Reader mu by Diagnoptics.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Endothelial function
Endothelial function will be measured through use of the itamar EndoPAT, which quantifies the endothelium-mediated changes in vascular tone elicited by a 5-minute occlusion of the brachial artery.
Time frame: 1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44
Plan to share: No — Upon request individual participant data will be available to other researchers.
This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Physicians Committee for Responsible Medicine