<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/NCT01729117</url>
  </required_header>
  <id_info>
    <org_study_id>HS-08-00646</org_study_id>
    <nct_id>NCT01729117</nct_id>
  </id_info>
  <brief_title>A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population</brief_title>
  <official_title>The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and Rationale Research studies have shown that patients with type 2 diabetes&#xD;
      (T2DM) who lose weight have better glucose control and less risk for heart disease. It has&#xD;
      been difficult to achieve these results in a non-research setting. Meal replacements (MR) are&#xD;
      pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight&#xD;
      loss program by reducing decision-making and facilitating target caloric intake. The&#xD;
      University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal&#xD;
      Clinic has demonstrated acceptability and success of MRs in conjunction with a structured&#xD;
      lifestyle modification program in achieving weight loss in underserved Hispanic T2DM&#xD;
      patients.&#xD;
&#xD;
      Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a&#xD;
      3-month full MR program in conjunction with a 1 year standardized lifestyle modification&#xD;
      program in a clinic setting. Our longer-term goal is to acquire data for sample size and&#xD;
      power estimates for a larger NIH- or other funded prospective, randomized trial.&#xD;
&#xD;
      Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated&#xD;
      with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The&#xD;
      SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive&#xD;
      MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1&#xD;
      consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month&#xD;
      transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of&#xD;
      a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600&#xD;
      calories/day for women and 1800 to 2000 calories/day for men. Individual and group&#xD;
      educational, support and counseling visits will be components of all 3 phases of the study.&#xD;
&#xD;
      Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to&#xD;
      hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and&#xD;
      12 months. These are all measurements that are done routinely in these patients. Safety will&#xD;
      be determined by monitoring of adverse events.&#xD;
&#xD;
      Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to&#xD;
      determine if there is evidence that the intervention improves outcomes and is safe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>12months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe Hypoglycemic Events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Meal Replacement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Meal Replacements will be provided to participants randomized to the MR group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard Care participants will receive standard care but no meal replacements</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal Replacement</intervention_name>
    <description>5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.</description>
    <arm_group_label>Meal Replacement</arm_group_label>
    <other_name>HMR70 Plus products; HMR Boston, Massachusetts</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Standard Care only</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Demographic&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Enrolled in the Roybal Diabetes Management Clinic&#xD;
&#xD;
          -  Self-described as Hispanic&#xD;
&#xD;
          -  Willing and able to participate in Spanish language group sessions.&#xD;
&#xD;
          -  Willing and able to attend study visits for the duration of the study at the allocated&#xD;
             times.&#xD;
&#xD;
          -  Willing and able to maintain a food exercise and medication log and perform and record&#xD;
             self-monitoring of blood glucose (SMBG) Clinical&#xD;
&#xD;
          -  T2DM diagnosed by fasting blood glucose &gt;126mg/dL or random blood glucose &gt;200mg/dL&#xD;
&#xD;
          -  BMI&gt;30 kg/m2&#xD;
&#xD;
          -  If a woman of childbearing potential, using effective contraception. Biochemical HbA1c&#xD;
             8%-12% Medication&#xD;
&#xD;
          -  On insulin therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medical conditions&#xD;
&#xD;
          -  Type 1 DM&#xD;
&#xD;
          -  Illness likely to lead to unstable weight or altered glucose control.&#xD;
&#xD;
          -  Proliferative diabetic retinopathy on eye examination within the last 6 months.&#xD;
&#xD;
          -  Gallstones suspected on clinical history or documented on ultrasound.&#xD;
&#xD;
          -  Serum creatinine &gt;1.5mg/dL&#xD;
&#xD;
          -  Symptomatic cardiovascular disease&#xD;
&#xD;
          -  Documented liver disease other than fatty liver&#xD;
&#xD;
          -  Lactating, pregnant or intending to become pregnant within the following year&#xD;
             Psycho-social conditions&#xD;
&#xD;
          -  Inability or unwillingness to participate in a Spanish-language lifestyle group.&#xD;
&#xD;
          -  Eating disorder such as bulimia&#xD;
&#xD;
          -  Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar&#xD;
             disorder.&#xD;
&#xD;
          -  Inability to attend scheduled appointments regularly for the duration of the study&#xD;
             Medication use&#xD;
&#xD;
          -  Use of weight loss medication within previous 3 months including exenatide.&#xD;
&#xD;
          -  Use of medication (other than diabetes medication) likely to lead to unstable weight&#xD;
             or altered glucose control&#xD;
&#xD;
          -  Laxative or substance abuse&#xD;
&#xD;
          -  More than 10 alcoholic drinks/week&#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>Elizabeth O Beale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roybal Diabetes Management Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Obesity</keyword>
  <keyword>Insulin</keyword>
  <keyword>Hispanic</keyword>
  <keyword>Low-income</keyword>
  <keyword>Meal replacement</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/NCT01729117
org study id: HS-08-00646
nct id: NCT01729117
lead sponsor: 
has dmc: No
Background and Rationale Research studies have shown that patients with type 2 diabetes
      (T2DM) who lose weight have better glucose control and less risk for heart disease. It has
      been difficult to achieve these results in a non-research setting. Meal replacements (MR) are
      pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight
      loss program by reducing decision-making and facilitating target caloric intake. The
      University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal
      Clinic has demonstrated acceptability and success of MRs in conjunction with a structured
      lifestyle modification program in achieving weight loss in underserved Hispanic T2DM
      patients.

      Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a
      3-month full MR program in conjunction with a 1 year standardized lifestyle modification
      program in a clinic setting. Our longer-term goal is to acquire data for sample size and
      power estimates for a larger NIH- or other funded prospective, randomized trial.

      Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated
      with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The
      SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive
      MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1
      consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month
      transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of
      a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600
      calories/day for women and 1800 to 2000 calories/day for men. Individual and group
      educational, support and counseling visits will be components of all 3 phases of the study.

      Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to
      hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and
      12 months. These are all measurements that are done routinely in these patients. Safety will
      be determined by monitoring of adverse events.

      Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to
      determine if there is evidence that the intervention improves outcomes and is safe.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in BMI
time frame: 12months
measure: Severe Hypoglycemic Events
time frame: 12 months
arm group label: Meal Replacement
arm group type: Other
description: Meal Replacements will be provided to participants randomized to the MR group
arm group label: Standard Care
arm group type: Other
description: Standard Care participants will receive standard care but no meal replacements
intervention type: Other
intervention name: Meal Replacement
description: 5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
arm group label: Meal Replacement
other name: HMR70 Plus products; HMR Boston, Massachusetts
intervention type: Other
intervention name: Standard Care
description: Standard Care only
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth O Beale, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2