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 range18 Years
SexALL
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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
✕. 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
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
9
HbA1c
Timeframe: 16-weeks
Trial details
NCT IDNCT06106035
SponsorPhysicians Committee for Responsible Medicine