Diabetes Reversal Online Program and Study (DROP Study)

Type 2 Diabetes Clinical Trial

— DROP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572502
• Other study ID #: Pro00066361
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Physicians Committee for Responsible Medicine
• Contact: VANITA RAHMAN, MD
• Phone: 2025277500
• Email: vrahman[@]pcrm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• plant-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

Locations

Country	Name	City	State
United States	Physician Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142. — View Citation

Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31.

Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.

Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153. — View Citation

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606. — View Citation

Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049. — View Citation

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004. — View Citation

Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.

Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7. — View Citation

U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	A1c will be measured before and after the study period	12 weeks
Secondary	body weight	participants will track body weight weekly using a RNFO scale	12 weeks
Secondary	total cholesterol	total cholesterol will be measured before and after the study period	12 weeks
Secondary	LDL cholesterol	LDL cholesterol will be measured before and after the study period	12 weeks
Secondary	medication usage	changes in medications to treat diabetes will be tracked during the study period	12 weeks