Effect of a Dietary Intervention on Intracellular Lipid Levels, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes

NCT04088981 | Withdrawn DMC

• 1 other identifier: Pro00037991
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

insulin sensitivity; glycemic control; intramyocellular; nutrition; hepatocellular

Outcome Measures

Primary Outcomes (6)

• Intramyocellular lipid content

  Proton magnetic resonance (MR) spectroscopy at 4T (Bruker) will be implemented to quantify intramyocellular lipid concentrations.

  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.

  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

  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.

  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.

  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.

  1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44

Secondary Outcomes (6)

• Resting energy expenditure

  Change from baseline to 22 weeks and change from 22 weeks to 44 weeks

• Postprandial metabolism

  Change from Baseline to 22 weeks and change from 22 weeks to 44 weeks

• Body Composition

  Change from baseline to 22 weeks and change from 22 weeks to 44 weeks

• Gut microbiome composition

  Change from baseline to 22 weeks and change from 22 weeks to 44 weeks

• Concentration of plasma lipids

  Change from baseline to 22 weeks and change from 22 weeks to 44 weeks

Other Outcomes (2)

• Advanced Glycation Endproducts (AGEs)

  1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44

• Endothelial function

  1.) Change from week 0 to week 22; 2.) Change from week 22 to week 44

Study Arms (2)

Low-fat, vegan diet

ACTIVE COMPARATOR

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

Portion-controlled diet

ACTIVE COMPARATOR

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

Interventions

Dietary intervention BEHAVIORAL

Low-fat, plant-based diet and a portion-controlled diet

Low-fat, vegan diet; Portion-controlled diet

Eligibility Criteria

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

You may qualify if:

• Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other that sulfonylureas
• Age ≥18 years
• Body mass index 26-40 kg/m2
• Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months
• HbA1c between 6-10.5% (42-88 mmol/mol)

You may not qualify if:

• Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas
• Metal implants, such as a cardiac pacemaker or an aneurysm clip
• History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome
• Smoking during the past six months
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Use of recreational drugs in the past 6 months
• Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, MAOIs, SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers
• Pregnancy or intention to become pregnant during the study period
• Unstable medical or psychiatric illness
• Evidence of an eating disorder
• Likely to be disruptive in group sessions
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead
• Yale University: collaborator

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Hana Kahleova, MD, PhD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, cross-over

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 13, 2019
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)