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

Description

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.

Conditions

Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2 in Obese

Study Overview

Study Details

Study overview

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.

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

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

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Washington

Physicians Committee for Responsible Medicine, Washington, District of Columbia, United States, 20016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Physicians Committee for Responsible Medicine,

Hana Kahleova, MD, PhD, PRINCIPAL_INVESTIGATOR, Physicians Committee for Responsible Medicine

Study Record Dates

2025-12