Diabetes Mellitus, Type 2PBNI-2NCT01700868
Practice Based Nutrition Intervention-2
A study testing Vegan diet and American Diabetes Association guidelines in people with Diabetes Mellitus, Type 2, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. 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?
- Vegan diet and American Diabetes Association guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2015
- 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
- a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
- male or female
- A1c between 6.5% and 10.5%
- age at least 18 years
- ability and willingness to participate in all components of the study
- willingness to be assigned to either a low-fat, vegan diet or to standard care
- diabetes medications unchanged for 1 month prior to volunteering for the study
- patient of Dr. Mark Sklar
Who cannot join
- body mass index >45 kg/m2
- alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- pregnancy
- history of severe mental illness (with current unstable status)
- likely to be disruptive in group sessions (as determined by research staff)
Show all 12Show fewer
- Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
- unstable medical status
- already following a low-fat, vegetarian diet
- an inordinate fear of blood draws
- inability to maintain current medication regimen
- lack of English fluency
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
This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes.
The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.
Read the detailed description
Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations. The within-group changes in these variables from baseline to week 20, one-year follow-up will be compared.
Specific Aim 2 tests the hypothesis that the vegan diet is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations in both the intervention and control groups. The between-groups differences in the changes in these variables from baseline to week 20, and one-year follow-up will be compared.
Specific Aim 3 tests the hypothesis that the vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.
This will be assessed by 3-day dietary records at weeks 0, 20 and one-year follow-up.
Specific Aim 4 tests the hypothesis that the vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.
This hypothesis will be addressed by quantitatively assessing adherence to and acceptability of the intervention and control diets, using the 3-day dietary record, the Food Acceptability Questionnaire, and the Eating Inventory, as described below.
Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 and B1 alleles of the DRD2 gene.
This will be assessed through Taq1 A1 and B1 genotype determination at baseline.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vegan diet, American Diabetes Association guidelines
- 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.
Vegan dietOther
Also called Plant-based diet
A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.
American Diabetes Association guidelinesOther
Also called ADA
Participants will follow individualized diet plans following ADA guidelines
| Study group | Role | What they receive |
|---|---|---|
| Vegan Group | Experimental | Participants in the intervention group will follow a low-fat, vegan diet for 20 weeks, and will attend nutrition classes in the form of a weekly support group. Receives: Other: Vegan diet |
| American Diabetes Association guidelines | Active comparator | Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes. Receives: Other: American Diabetes Association guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1C (diabetes management)
Measured: 20 weeks
Secondary outcomes (17)
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
Height
Measured: 20 Weeks
24-Hour Multi-Pass Dietary Recalls
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 posted4 Oct 2012 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Barnard, MD, Principal investigator, Physicians Committee for Responsible Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700868
- Sponsor's protocol ID
- PBNI-2
- Acronym
- PBNI-2
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2012
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Based Nutrition Intervention-2
- ClinicalTrials.gov ID
- NCT01700868
- Acronym / sponsor ID
- PBNI-2 / PBNI-2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Oct 2012 (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.
This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes.
The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.
Detailed description
Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations. The within-group changes in these variables from baseline to week 20, one-year follow-up will be compared.
Specific Aim 2 tests the hypothesis that the vegan diet is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations in both the intervention and control groups. The between-groups differences in the changes in these variables from baseline to week 20, and one-year follow-up will be compared.
Specific Aim 3 tests the hypothesis that the vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.
This will be assessed by 3-day dietary records at weeks 0, 20 and one-year follow-up.
Specific Aim 4 tests the hypothesis that the vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.
This hypothesis will be addressed by quantitatively assessing adherence to and acceptability of the intervention and control diets, using the 3-day dietary record, the Food Acceptability Questionnaire, and the Eating Inventory, as described below.
Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 and B1 alleles of the DRD2 gene.
This will be assessed through Taq1 A1 and B1 genotype determination at baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Group | Experimental | Other: Vegan dietParticipants in the intervention group will follow a low-fat, vegan diet for 20 weeks, and will attend nutrition classes in the form of a weekly support group. |
| American Diabetes Association guidelines | Active comparator | Other: American Diabetes Association guidelinesParticipants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
- male or female
- A1c between 6.5% and 10.5%
- age at least 18 years
- ability and willingness to participate in all components of the study
Key exclusion criteria (12 listed)
- body mass index >45 kg/m2
- alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- pregnancy
- history of severe mental illness (with current unstable status)
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 |
|---|---|---|
| Vegan dietAlso: Plant-based dietA diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet. | Other | Vegan Group |
| American Diabetes Association guidelinesAlso: ADAParticipants will follow individualized diet plans following ADA guidelines | Other | American Diabetes Association guidelines |
Primary outcome
hemoglobin A1C (diabetes management)
Time frame: 20 weeks
17 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
Height
Time frame: 20 Weeks
24-Hour Multi-Pass Dietary Recalls
Time frame: 20 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- 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.
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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.
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 Vegan diet and American Diabetes Association guidelines 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 20 Oct 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (diabetes management) (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 NCT01700868, 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 20 Oct 2015.