Diabetes Reversal Online Program and Study (DROP Study)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhysicians Committee for Responsible Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • plant-based diet

    Behavioral

    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

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Vegan dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Glycated hemoglobin

A1c will be measured before and after the study period

Time frame
12 weeks

Secondary outcomes

1

body weight

participants will track body weight weekly using a RNFO scale

Time frame
12 weeks
2

total cholesterol

total cholesterol will be measured before and after the study period

Time frame
12 weeks
3

LDL cholesterol

LDL cholesterol will be measured before and after the study period

Time frame
12 weeks
4

medication usage

changes in medications to treat diabetes will be tracked during the study period

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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