Diabetes Mellitus, Type 2WCCR-DIAB2NCT01931631
Plant-Based Dietary Intervention in Type 2 Diabetes-2
A study testing Low-fat, low-Glycemic Index, vegan diet and ADA diet in people with Diabetes Mellitus, Type 2, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Low-fat, low-Glycemic Index, vegan diet and ADA diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus
Who cannot join
- hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016
About this study
Official title: A Practice-Based, Nutrition Intervention in Type 2 Diabetes
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.
Read the detailed description
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Low-fat, low-Glycemic Index, vegan diet, ADA diet
- Keywords
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat, low-Glycemic Index, vegan dietBehavioural
Low-fat, low-Glycemic Index, vegan diet
ADA dietBehavioural
Diet in accordance with the American Diabetes Association
| Study group | Role | What they receive |
|---|---|---|
| Low-fat, low-Glycemic Index, vegan diet | Experimental | Low-fat, low-Glycemic Index, vegan diet Receives: Behavioral: Low-fat, low-Glycemic Index, vegan diet |
| ADA diet | Active comparator | American Diabetes Association diet Receives: Behavioral: ADA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measured: 20 weeks
Secondary outcomes (15)
Body Weight
Measured: 20 Weeks
Blood Pressure
Measured: 20 Weeks
Glucose
Measured: 20 Weeks
Comprehensive Metabolic Panel
Measured: 20 Weeks & one-year follow up
Serum cholesterol and triacylglycerol concentrations
Measured: 20 Weeks
Urinary albumin and creatinine
Measured: 20 Weeks
Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
Measured: 20 Weeks
Waist and hip circumference
Measured: 20 Weeks
Dietary Acceptability
Measured: 20 Weeks
3-day dietary records
Measured: 20 Weeks
International Physical Activity Questionnaire
Measured: 20 Weeks
Food Acceptability Questionnaire
Measured: 20 Weeks
Eating Inventory
Measured: 20 Weeks
CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
Measured: 20 Weeks
Beck Depression Inventory II (BDI-II)
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJan 2014 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: This study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Sponsor
- Investigators
- Joshua Cohen, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931631
- Sponsor's protocol ID
- PCRM GWU DM Study-2
- Acronym
- WCCR-DIAB2
- Status last verified
- Jun 2025
- First submitted
- 26 Aug 2013
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data was collected because the study was never initiated.
Publications
Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
PubMed 9863851Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
PubMed 10496449Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529.
PubMed 10446033
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practice-Based, Nutrition Intervention in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01931631
- Acronym / sponsor ID
- WCCR-DIAB2 / PCRM GWU DM Study-2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- Jan 2014 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- 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.
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.
Detailed description
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat, low-Glycemic Index, vegan diet | Experimental | Behavioral: Low-fat, low-Glycemic Index, vegan dietLow-fat, low-Glycemic Index, vegan diet |
| ADA diet | Active comparator | Behavioral: ADA dietAmerican Diabetes Association diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Type 2 Diabetes Mellitus
Key exclusion criteria (1 listed)
- hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.
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 |
|---|---|---|
| Low-fat, low-Glycemic Index, vegan dietLow-fat, low-Glycemic Index, vegan diet | Behavioural | Low-fat, low-Glycemic Index, vegan diet |
| ADA dietDiet in accordance with the American Diabetes Association | Behavioural | ADA diet |
Primary outcome
Hemoglobin A1c
Time frame: 20 weeks
15 secondary outcomes
Body Weight
Time frame: 20 Weeks
Blood Pressure
Time frame: 20 Weeks
Glucose
Time frame: 20 Weeks
Comprehensive Metabolic Panel
Time frame: 20 Weeks & one-year follow up
Serum cholesterol and triacylglycerol concentrations
Time frame: 20 Weeks
Urinary albumin and creatinine
Time frame: 20 Weeks
Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
Time frame: 20 Weeks
Waist and hip circumference
Time frame: 20 Weeks
Dietary Acceptability
Time frame: 20 Weeks
3-day dietary records
Time frame: 20 Weeks
International Physical Activity Questionnaire
Time frame: 20 Weeks
Food Acceptability Questionnaire
Time frame: 20 Weeks
Eating Inventory
Time frame: 20 Weeks
CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
Time frame: 20 Weeks
Beck Depression Inventory II (BDI-II)
Time frame: 20 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 9863851Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
- Background: PubMed 10496449Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
- Background: PubMed 10446033Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529.
- Individual participant dataSharing planned: No. No data was collected because the study was never initiated.
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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. This study is not recruiting at the moment.
Joshua Cohen, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat, low-Glycemic Index, vegan diet and ADA diet in people with Diabetes Mellitus, Type 2, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 20 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 NCT01931631, which also lists 3 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 1 Jul 2025.