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NCT Number: NCT05572502

Diabetes Reversal Online Program and Study (DROP Study)

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physician Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location status: Recruiting

Location contact

James Loomis, MD

SUB_INVESTIGATOR

Roxanne Becker, MBChB

CONTACT

[email protected]

2022779760

Shannon Gray, RD

SUB_INVESTIGATOR

VANITA RAHMAN, MD

CONTACT

[email protected]

202-527-7500

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: vegan diet

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 12 weeks

    A1c will be measured before and after the study period

Secondary outcomes

  1. body weight

    Time frame: 12 weeks

    participants will track body weight weekly using a RNFO scale

  2. total cholesterol

    Time frame: 12 weeks

    total cholesterol will be measured before and after the study period

  3. LDL cholesterol

    Time frame: 12 weeks

    LDL cholesterol will be measured before and after the study period

  4. medication usage

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Roxanne Becker, MBChB

CONTACT

[email protected]

2022779760

VANITA RAHMAN, MD

CONTACT

[email protected]

2025277500

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Official study title

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

Acronym: DROP

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Oct 7, 2022
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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