NCT06106035Completed
The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 24 Oct 2023
- Start date
- 13 Feb 2024
- Primary completion date
- 28 Nov 2025
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06106035
What you commit to
- Study type: Interventional
- Participants enrolled: 26
- From 13 Feb 2024 to the primary completion date, 28 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas
- 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
- Inability to maintain current medication regimen
Other illness
- 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
- 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
- Unstable medical or psychiatric illness
- Evidence of an eating disorder
Other
- Smoking during the past six months
- Pregnancy or intention to become pregnant during the study period
- Likely to be disruptive in group sessions
- Already following a low-fat, vegan diet
- Lack of English fluency
- Inability or unwillingness to participate in all components of the study
- Intention to follow another weight-loss method during the trial
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Physicians Committee for Responsible Medicine Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- Changes in ectopic lipids, insulin sensitivity, and beta cell function after a low-fat vegan diet in adults with type 2 diabetes: a 16-week single-arm clinical trial.BMJ Open Diabetes Res Care · 2026 · PMID 42850024
This page is information, not medical advice. Discuss any trial with your doctor.