Status:
RECRUITING
The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, 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
Diabetes Mellitus Type 2 in Obese
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this 16-week clinical trial is to assess the health benefits of a low-fat vegan diet on insulin sensitivity and glycemic control in type 2 diabetes. Participants will receive at no cost, s...
Detailed Description
This study tests the hypothesis that fat content in muscle and liver cells will be reduced and changes in insulin sensitivity will be observed in response to a low-fat vegan diet intervention. The st...
Eligibility Criteria
Inclusion
- Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other than 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 6.0-10.5% (42-91 mmol/mol)
Exclusion
- 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, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), 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
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06106035
Start Date
February 13 2024
End Date
December 1 2025
Last Update
June 3 2025
Active Locations (1)
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1
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States, 20016