Diabetes Reversal Online Program and Study (DROP Study)

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: plant-based diet

• Registration Number: NCT05572502
• Lead Sponsor: Physicians Committee for Responsible Medicine

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.

Detailed Description

This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 12-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Study Start: 2023-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-08-28
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vegan diet	plant-based diet	All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	12 weeks	A1c will be measured before and after the study period

Secondary Outcome Measures

Name	Time	Method
body weight	12 weeks	participants will track body weight weekly using a RNFO scale
total cholesterol	12 weeks	total cholesterol will be measured before and after the study period
LDL cholesterol	12 weeks	LDL cholesterol will be measured before and after the study period
medication usage	12 weeks	changes in medications to treat diabetes will be tracked during the study period

Trial Locations

Locations (1)

Physician Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States