<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01700868</url>
  </required_header>
  <id_info>
    <org_study_id>PBNI-2</org_study_id>
    <nct_id>NCT01700868</nct_id>
  </id_info>
  <brief_title>Practice Based Nutrition Intervention-2</brief_title>
  <acronym>PBNI-2</acronym>
  <official_title>Practice Based Nutrition Intervention-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Physicians Committee for Responsible Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Physicians Committee for Responsible Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to test hypotheses that are potentially important to diabetes management,&#xD;
      with practical implications for reducing the medical, personal, and economic costs of the&#xD;
      disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are&#xD;
      significantly greater than those achievable with current diet recommendations, reductions in&#xD;
      medication use among many intervention-group participants, beneficial changes in body weight&#xD;
      and serum lipid concentrations, and a demonstration of the acceptability of the intervention&#xD;
      diet. Progress toward these goals could refine dietary guidance for individuals with&#xD;
      diabetes, increase treatment expectations, and reduce the massive burden the disease&#xD;
      currently imposes.&#xD;
&#xD;
      The study further attempts to translate a dietary intervention studied in a clinical research&#xD;
      setting to a medical practice. This will contribute to developing a model for diabetes care&#xD;
      that can be used widely.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan&#xD;
      diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma&#xD;
      lipid concentrations, blood pressure, and indices of renal function in a within-group&#xD;
      analysis.&#xD;
&#xD;
      Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose&#xD;
      and urinary albumin and creatinine concentrations. The within-group changes in these&#xD;
      variables from baseline to week 20, one-year follow-up will be compared.&#xD;
&#xD;
      Specific Aim 2 tests the hypothesis that the vegan diet is more effective than standard&#xD;
      nutrition care for improving glycemic control, body weight, plasma lipid concentrations,&#xD;
      blood pressure, and indices of renal function in individuals with type 2 diabetes.&#xD;
&#xD;
      Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose&#xD;
      and urinary albumin and creatinine concentrations in both the intervention and control&#xD;
      groups. The between-groups differences in the changes in these variables from baseline to&#xD;
      week 20, and one-year follow-up will be compared.&#xD;
&#xD;
      Specific Aim 3 tests the hypothesis that the vegan diet is sustainable among individuals with&#xD;
      type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one&#xD;
      year with limited professional support.&#xD;
&#xD;
      This will be assessed by 3-day dietary records at weeks 0, 20 and one-year follow-up.&#xD;
&#xD;
      Specific Aim 4 tests the hypothesis that the vegan diet has an acceptability that is&#xD;
      comparable to that of standard nutrition care among individuals with type 2 diabetes.&#xD;
&#xD;
      This hypothesis will be addressed by quantitatively assessing adherence to and acceptability&#xD;
      of the intervention and control diets, using the 3-day dietary record, the Food Acceptability&#xD;
      Questionnaire, and the Eating Inventory, as described below.&#xD;
&#xD;
      Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and&#xD;
      body weight are reduced in individuals with the A1 and B1 alleles of the DRD2 gene.&#xD;
&#xD;
      This will be assessed through Taq1 A1 and B1 genotype determination at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hemoglobin A1C (diabetes management)</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Metabolic Panel</measure>
    <time_frame>20 Weeks &amp; one-year follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cholesterol and triacylglycerol concentrations</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary albumin and creatinine</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist and hip circumference</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Acceptability</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-day dietary records</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Acceptability Questionnaire</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Inventory</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory II (BDI-II)</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-Hour Multi-Pass Dietary Recalls</measure>
    <time_frame>20 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Vegan Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>American Diabetes Association guidelines</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vegan diet</intervention_name>
    <description>A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.</description>
    <arm_group_label>Vegan Group</arm_group_label>
    <other_name>Plant-based diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>American Diabetes Association guidelines</intervention_name>
    <description>Participants will follow individualized diet plans following ADA guidelines</description>
    <arm_group_label>American Diabetes Association guidelines</arm_group_label>
    <other_name>ADA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose&#xD;
             concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2&#xD;
             diabetes with the use of hypoglycemic medications for at least 6 months&#xD;
&#xD;
          2. male or female&#xD;
&#xD;
          3. A1c between 6.5% and 10.5%&#xD;
&#xD;
          4. age at least 18 years&#xD;
&#xD;
          5. ability and willingness to participate in all components of the study&#xD;
&#xD;
          6. willingness to be assigned to either a low-fat, vegan diet or to standard care&#xD;
&#xD;
          7. diabetes medications unchanged for 1 month prior to volunteering for the study&#xD;
&#xD;
          8. patient of Dr. Mark Sklar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. body mass index &gt;45 kg/m2&#xD;
&#xD;
          2. alcohol consumption of more than 2 drinks per day or the equivalent, episodic&#xD;
             increased drinking (e.g., more than 2 drinks per day on weekends), or a history of&#xD;
             alcohol abuse or dependency followed by any current use&#xD;
&#xD;
          3. use of recreational drugs in the past 6 months (past drug use, if fully recovered, is&#xD;
             not a criteria for exclusion)&#xD;
&#xD;
          4. pregnancy&#xD;
&#xD;
          5. history of severe mental illness (with current unstable status)&#xD;
&#xD;
          6. likely to be disruptive in group sessions (as determined by research staff)&#xD;
&#xD;
          7. Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria,&#xD;
             polydipsia, blurred vision, uncontrolled weight loss)&#xD;
&#xD;
          8. unstable medical status&#xD;
&#xD;
          9. already following a low-fat, vegetarian diet&#xD;
&#xD;
         10. an inordinate fear of blood draws&#xD;
&#xD;
         11. inability to maintain current medication regimen&#xD;
&#xD;
         12. lack of English fluency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neal Barnard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Committee for Responsible Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Committee for Responsible Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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. Erratum In: JAMA 1999 Apr 21;281(15):1380.</citation>
    <PMID>9863851</PMID>
  </reference>
  <reference>
    <citation>Esselstyn 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.</citation>
    <PMID>10496449</PMID>
  </reference>
  <reference>
    <citation>Nicholson 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.</citation>
    <PMID>10446033</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Diet, Vegetarian</keyword>
  <keyword>Diet, Fat-Restricted</keyword>
  <keyword>Glycemic Index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01700868
org study id: PBNI-2
nct id: NCT01700868
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: hemoglobin A1C (diabetes management)
time frame: 20 weeks
measure: Body Weight
time frame: 20 Weeks
measure: Blood Pressure
time frame: 20 Weeks
measure: Glucose
time frame: 20 Weeks
measure: Comprehensive Metabolic Panel
time frame: 20 Weeks & one-year follow up
measure: Serum cholesterol and triacylglycerol concentrations
time frame: 20 Weeks
measure: Urinary albumin and creatinine
time frame: 20 Weeks
measure: Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
time frame: 20 Weeks
measure: Waist and hip circumference
time frame: 20 Weeks
measure: Dietary Acceptability
time frame: 20 Weeks
measure: 3-day dietary records
time frame: 20 Weeks
measure: International Physical Activity Questionnaire
time frame: 20 Weeks
measure: Food Acceptability Questionnaire
time frame: 20 Weeks
measure: Eating Inventory
time frame: 20 Weeks
measure: CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
time frame: 20 Weeks
measure: Beck Depression Inventory II (BDI-II)
time frame: 20 Weeks
measure: Height
time frame: 20 Weeks
measure: 24-Hour Multi-Pass Dietary Recalls
time frame: 20 Weeks
arm group label: Vegan Group
arm group type: Experimental
description: 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.
arm group label: American Diabetes Association guidelines
arm group type: Active Comparator
description: Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.
intervention type: Other
intervention name: Vegan diet
description: A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.
arm group label: Vegan Group
other name: Plant-based diet
intervention type: Other
intervention name: American Diabetes Association guidelines
description: Participants will follow individualized diet plans following ADA guidelines
arm group label: American Diabetes Association guidelines
other name: ADA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Barnard, MD
role: Principal Investigator
affiliation: Physicians Committee for Responsible Medicine
facility: 
country: United States
citation: 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. Erratum In: JAMA 1999 Apr 21;281(15):1380.
PMID: 9863851
citation: Esselstyn 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.
PMID: 10496449
citation: Nicholson 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.
PMID: 10446033
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2