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Diabetes Reversal Online Program and Study (DROP Study)

P

Physicians Committee for Responsible Medicine

Status

Enrolling

Conditions

Type 2 Diabetes

Treatments

Behavioral: plant-based diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05572502
Pro00066361

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

VANITA RAHMAN, MD; Roxanne Becker, MBChB

Data sourced from clinicaltrials.gov

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