Type 2 DiabetesDROPNCT05572502
Diabetes Reversal Online Program and Study (DROP Study)
A study testing plant-based diet in people with Type 2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- plant-based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Physician Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016
VANITA RAHMAN, MD, 202-527-7500, vrahman@pcrm.org
Roxanne Becker, MBChB, 2022779760, rbecker@pcrm.org
About this study
Official title: The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- plant-based diet
- Keywords
- plant-based, vegan, diet, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based dietBehavioural
Also called vegan 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
| Study group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | All participants will follow a low-fat vegan diet. There are no other study arms or control group. Receives: Behavioral: plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
A1c will be measured before and after the study period
Measured: 12 weeks
Secondary outcomes (4)
body weight
participants will track body weight weekly using a RNFO scale
Measured: 12 weeks
total cholesterol
total cholesterol will be measured before and after the study period
Measured: 12 weeks
LDL cholesterol
LDL cholesterol will be measured before and after the study period
Measured: 12 weeks
medication usage
changes in medications to treat diabetes will be tracked during the study period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start21 Sep 2023
- Primary completion28 Aug 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, multiple replications
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanita Rahman, Physicians Committee for Responsible Medicine
- Investigators
- Neal Barnard, MD, Principal investigator, Physicians Committee for Responsible Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572502
- Sponsor's protocol ID
- Pro00066361
- Acronym
- DROP
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19351712Barnard 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.
PubMed 16873779Barnard 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, 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.
PubMed 15286527Barnard 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.
PubMed 19167953American 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.
PubMed 12778049Barnard 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.
PubMed 7842153Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.
U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
- ClinicalTrials.gov ID
- NCT05572502
- Acronym / sponsor ID
- DROP / Pro00066361
- Conditions
- Type 2 Diabetes
- Keywords
- plant-based, vegan, diet, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 28 Aug 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, multiple replications
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Behavioral: plant-based dietAll participants will follow a low-fat vegan diet. There are no other study arms or control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant-based dietAlso: vegan dietFor 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 | Behavioural | Vegan diet |
Primary outcome
Glycated hemoglobin
Time frame: 12 weeks
A1c will be measured before and after the study period
4 secondary outcomes
body weight
Time frame: 12 weeks
total cholesterol
Time frame: 12 weeks
LDL cholesterol
Time frame: 12 weeks
medication usage
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 19351712Tonstad 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.
- Background: PubMed 16873779Barnard 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.
- BackgroundBarnard 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.
- BackgroundBarnard 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.
- Background: PubMed 15286527Barnard 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.
- Background: PubMed 19167953Barnard 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.
- Background: PubMed 12778049American 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.
- Background: PubMed 7842153Barnard 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.
- BackgroundBecker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.
- BackgroundU.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neal Barnard, MD principal investigator
Physicians Committee for Responsible Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant-based diet in people with Type 2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VANITA RAHMAN, MD (2025277500, vrahman@pcrm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572502, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.