Low-fat vegan diet's impact on diabetes management
The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
This study is testing if a low-fat vegan diet can help people with type 2 diabetes manage their blood sugar and improve their overall health over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Physicians Committee for Responsible Medicine Academic / other |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06106035 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a low-fat vegan diet on insulin sensitivity and glycemic control in individuals with type 2 diabetes over a 16-week period. Participants will receive weekly online nutrition education classes and one-on-one consultations with a registered dietitian. The study will involve both online and in-person components, including bloodwork and medical tests at designated locations to assess changes in fat content in muscle and liver cells. The hypothesis is that the low-fat vegan diet will lead to improved metabolic health markers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 2 diabetes who are managing their condition through diet and/or oral medications, and have a BMI between 26-40 kg/m2.
Not a fit: Patients with type 1 diabetes, those using insulin or sulfonylureas, or individuals with certain medical conditions affecting weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve insulin sensitivity and glycemic control for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with dietary interventions for diabetes management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other than 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 6.0-10.5% (42-91 mmol/mol) Exclusion Criteria: 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, 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 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
Where this trial is running
Washington, District of Columbia
- Physicians Committee for Responsible Medicine — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Hana Kahleova, MD, PhD — Physicians Committee for Responsible Medicine
- Study coordinator: Tatiana Znayenko-Miller
- Email: tznayenkomiller@pcrm.org
- Phone: 202-527-7317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.