Clinical trial NCT05572502: Diabetes Reversal Online Program and Study (DROP Study)
Official title: The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: plant-based
vegan
diet
obesity
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group, multiple replications
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 12 weeks
Secondary outcomes:
measure: body weight
timeFrame: 12 weeks
measure: total cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: 12 weeks
measure: medication usage
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physician Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: Physicians Committee for Responsible Medicine
name: Neal Barnard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
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citation: U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.