Recruiting

Diabetes Reversal

Sponsor:

Physicians Committee for Responsible Medicine

Code:

NCT05572502

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

plant-based diet

Study Details

Brief summary:

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.

Conditions

Type 2 Diabetes

Study ID

NCT05572502

Start date

Sep 21, 2023

Status verified date

Apr, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states
  • Prior diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

  • Use of recreational drugs in the past 6 months
  • Pregnancy or intention to become pregnant during the study period, as verified by self-report
  • Unstable medical or psychiatric illness
  • Lack of English fluency
  • Inability to maintain current medication regimen
  • Inability or unwillingness to participate in all components of the study

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vegan diet

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Interventions

plant-based diet

For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study

Primary outcome measure

  • Glycated hemoglobin [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

VANITA RAHMAN, MD

2025277500vrahman@pcrm.org

Roxanne Becker, MBChB

2022779760rbecker@pcrm.org

Locations

Physician Committee for Responsible Medicine

Recruiting

Washington, District of Columbia, United States, 20016

Contacts

VANITA RAHMAN, MD

202-527-7500vrahman@pcrm.org

Roxanne Becker, MBChB

2022779760rbecker@pcrm.org

More Information

Sponsor

Physicians Committee for Responsible Medicine

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • plant-based
  • vegan
  • diet
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Physicians Committee for Responsible Medicine on 2024-04-18.