Status:
WITHDRAWN
Effect of a Dietary Intervention on Intracellular Lipid Levels, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
Lead Sponsor:
Physicians Committee for Responsible Medicine
Collaborating Sponsors:
Yale University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- Inclusion criteria are as follows:
- 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)
- Exclusion criteria are as follows:
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04088981
Start Date
July 1 2025
End Date
July 1 2026
Last Update
June 27 2025
Active Locations (1)
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1
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States, 20016