The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, a… (NCT06106035) | Clinical Trial Compass
CompletedNot Applicable
The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
United States26 participantsStarted 2024-02-13
Plain-language 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, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intramyocellular and Hepatocellular Lipid Content
Timeframe: 16-weeks
2
Insulin sensitivity and β-cell function
Timeframe: 16-weeks
3
Resting energy expenditure and postprandial metabolism
Timeframe: 16-weeks
4
Body Composition
Timeframe: 16-weeks
5
Advanced Glycation End-products (AGE)
Timeframe: 16-weeks
6
Continuous glucose monitoring
Timeframe: 16-weeks
7
Body Weight
Timeframe: 16-weeks
8
Plasma Lipid Concentrations
Timeframe: 16-weeks
Trial details
NCT IDNCT06106035
SponsorPhysicians Committee for Responsible Medicine
. 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