search
Back to results

Diabetes Reversal Online Program and Study (DROP Study) (DROP)

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
plant-based diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring plant-based, vegan, diet, obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physician Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vegan diet

Arm Description

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Outcomes

Primary Outcome Measures

Glycated hemoglobin
A1c will be measured before, during and after the study period

Secondary Outcome Measures

body weight
participants will track body weight weekly using a RNFO scale
total cholesterol
total cholesterol will be measured before, during and after the study period
LDL cholesterol
LDL cholesterol will be measured before, during and after the study period
medication usage
changes in medications to treat diabetes will be tracked during the study period

Full Information

First Posted
October 3, 2022
Last Updated
March 1, 2023
Sponsor
Physicians Committee for Responsible Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05572502
Brief Title
Diabetes Reversal Online Program and Study (DROP Study)
Acronym
DROP
Official Title
The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 20-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 20-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
plant-based, vegan, diet, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group, multiple replications
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vegan diet
Arm Type
Experimental
Arm Description
All participants will follow a low-fat vegan diet. There are no other study arms or control group.
Intervention Type
Behavioral
Intervention Name(s)
plant-based diet
Other Intervention Name(s)
vegan diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Description
A1c will be measured before, during and after the study period
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
body weight
Description
participants will track body weight weekly using a RNFO scale
Time Frame
20 weeks
Title
total cholesterol
Description
total cholesterol will be measured before, during and after the study period
Time Frame
20 weeks
Title
LDL cholesterol
Description
LDL cholesterol will be measured before, during and after the study period
Time Frame
20 weeks
Title
medication usage
Description
changes in medications to treat diabetes will be tracked during the study period
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VANITA RAHMAN, MD
Phone
2025277500
Email
vrahman@pcrm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Smith, RD
Phone
2025277500
Email
ksmith@pcrm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Barnard, MD
Organizational Affiliation
Physicians Committee for Responsible Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physician Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VANITA RAHMAN, MD
Phone
202-527-7500
Email
vrahman@pcrm.org
First Name & Middle Initial & Last Name & Degree
Karen Smith, RD
Phone
2025277500
Email
ksmith@pcrm.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19351712
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.
Results Reference
background
PubMed Identifier
16873779
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
15286527
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.
Results Reference
background
PubMed Identifier
19167953
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.
Results Reference
background
PubMed Identifier
12778049
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.
Results Reference
background
PubMed Identifier
7842153
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.
Results Reference
background
Citation
Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.
Results Reference
background
Citation
U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.
Results Reference
background

Learn more about this trial

Diabetes Reversal Online Program and Study (DROP Study)

We'll reach out to this number within 24 hrs