Low-Fat, Plant-Based Diet vs. Portion-Controlled Diet for Intracellular Lipid Reduction in Type 2 Diabetes
This study compares the effects of a low-fat, plant-based diet and a portion-controlled diet on reducing intracellular lipids in individuals with type 2 diabetes, by measuring C-peptide concentration, glucose levels, hepatocellular and intramyocellular lipid content, insulin sensitivity, and rate of glycemic control.
Dietary intervention
Diabetes Mellitus+5
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This study focuses on Type 2 diabetes, a condition where the body's insulin production doesn't meet its needs, often linked to excess fat in liver and muscle cells. The research aims to compare the effects of two dietary interventions: a low-fat, plant-based diet and a portion-controlled diet that aligns with current American Diabetes Association guidelines. The goal is to see how these diets impact fat content in liver and muscle cells in adults with Type 2 diabetes. This study is important as it could provide insights into dietary strategies for improving insulin sensitivity and managing Type 2 diabetes. Participants with Type 2 diabetes will be randomly assigned to start with either the plant-based or the portion-controlled diet for 22 weeks, then switch to the other diet for another 22 weeks. Before and after each diet period, researchers will measure fat content in muscle and liver cells. They will also evaluate insulin sensitivity and blood sugar control. The study anticipates that both diets will reduce fat content in these cells, leading to improved insulin sensitivity and blood sugar control. However, it is hypothesized that the low-fat, plant-based diet will result in greater changes in cellular fat content compared to the portion-controlled diet.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion criteria are as follows: 1. Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other that sulfonylureas 2. Age ≥18 years 3. Body mass index 26-40 kg/m2 4. Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months 5. HbA1c between 6-10.5% (42-88 mmol/mol) Exclusion criteria are as follows: 1. Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas 2. Metal implants, such as a cardiac pacemaker or an aneurysm clip 3. History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome 4. Smoking during the past six months 5. 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 6. Use of recreational drugs in the past 6 months 7. 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 8. Pregnancy or intention to become pregnant during the study period 9. Unstable medical or psychiatric illness 10. Evidence of an eating disorder 11. Likely to be disruptive in group sessions 12. Already following a low-fat, vegan diet 13. Lack of English fluency 14. Inability to maintain current medication regimen 15. Inability or unwillingness to participate in all components of the study 16. Intention to follow another weight-loss method during the trial Participants will also review and complete the Yale MRI Safety Questionnaire to determine eligibility for the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Physicians Committee for Responsible Medicine
Washington D.C., United StatesOpen Physicians Committee for Responsible Medicine in Google Maps