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Diabetes Reversal Online Program and Study (DROP Study)

The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05572502
Acronym
DROP
Enrollment
150
Registered
2022-10-07
Start date
2023-09-21
Completion date
2027-12-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

plant-based, vegan, diet, obesity

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.

Interventions

BEHAVIORALplant-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

Sponsors

Physicians Committee for Responsible Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

single group, multiple replications

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycated hemoglobin12 weeksA1c will be measured before and after the study period

Secondary

MeasureTime frameDescription
body weight12 weeksparticipants will track body weight weekly using a RNFO scale
total cholesterol12 weekstotal cholesterol will be measured before and after the study period
LDL cholesterol12 weeksLDL cholesterol will be measured before and after the study period
medication usage12 weekschanges in medications to treat diabetes will be tracked during the study period

Countries

United States

Contacts

Primary ContactVANITA RAHMAN, MD
vrahman@pcrm.org2025277500
Backup ContactRoxanne Becker, MBChB
rbecker@pcrm.org2022779760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026