The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes

Physicians Committee for Responsible Medicine

Status

Enrolling

Conditions

Diabetes Mellitus Type 2 in Obese

Diabetes Mellitus, Type 2

Treatments

Behavioral: low-fat vegan diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06106035

Pro00074571

Details and patient eligibility

About

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.

Full 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 study will be carried out online (via Zoom or a similar platform). Participants will be asked to attend weekly online classes on nutrition and health.

The study will also require in-person meetings. Participants will travel to the Physicians Committee of Responsible Medicine, Washington, DC, at the beginning of the study (week 0) and the end of the study (week 16) to complete bloodwork (comprehensive metabolic panel, lipid panel, and HbA1c) and several medical tests (standard meal test, indirect calorimetry, dual-energy x-ray absorptiometry [DEXA Scan, an imaging test that measures changes in bone mineral density/bone strength], and Advanced Glycation End-products measurement). They will also need to travel to the Magnetic Research Center at Yale University School of Medicine, New Haven, CT at the beginning of the study (week 0) and the end of the study (week 16) to have a Magnetic Resonance (MR) spectroscopy to quantify liver and muscle fat content.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
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