<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/NCT01702012</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00020672</org_study_id>
    <nct_id>NCT01702012</nct_id>
  </id_info>
  <brief_title>Almased Multi-Center Diabetes Intervention Trial</brief_title>
  <acronym>AMDIT</acronym>
  <official_title>Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Freiburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Mysore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 12 month multi-center randomization controlled study. Participants will be randomized to&#xD;
      either a lifestyle education program or a meal replacement regimen with Almased, after an&#xD;
      initial examination of eligibility criteria.&#xD;
&#xD;
      Primary outcome-HbA1c&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c&#xD;
      7.5-10%&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c (%)</measure>
    <time_frame>2, 4, 6, 8, 10, and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA IR Index</measure>
    <time_frame>2, 4, 6, 8, 10, and 12 months</time_frame>
    <description>measure changes in Homeostasis Model of Insulin Resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood glucose (mg/dl)</measure>
    <time_frame>2, 4, 6, 8, 10, and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Almased Meal Replacement Powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this arm will receive the Almased meal replacement powder and will be asked to replace one meal per day during the first 6 months of participation. During the second 6 months, participants will be allowed to choose whether to continue using the product to replace a meal or to use the product as a supplement prior to meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this group will receive 5 group sessions in the first two months of participation and 5 additional group sessions in the last two months. These group sessions will focus on lifestyle behavior changes for weight loss and management including goal-setting, calorie balance, general nutrition, and physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Almased Meal Replacement Powder</intervention_name>
    <description>Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals.</description>
    <arm_group_label>Almased Meal Replacement Powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group-Based Lifestyle Intervention</intervention_name>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:• Gender: Men and women are eligible&#xD;
&#xD;
          -  Type 2 diabetes mellitus: Diabetes mellitus will be determined by medical records,&#xD;
             current treatment, verification from personal health care provider, or test results&#xD;
             meeting the 2010 American Diabetes Association criteria of fasting glucose ≥126 mg/dl,&#xD;
             symptoms of hyperglycemia with casual plasma glucose &gt; 200 mg/dl or two-hour plasma&#xD;
             glucose ≥200 mg/dl after a 75 gram oral glucose load. Individuals who have a clinical&#xD;
             history strongly suggestive of type 1 diabetes will be excluded. Individuals taking&#xD;
             oral hypoglycemic medication with diet and exercise are eligible. Subjects taking&#xD;
             insulin will not be eligible for entry into the study.&#xD;
&#xD;
          -  Body mass index: Overweight and obese individuals, with body mass index 25 - 40 kg/m2,&#xD;
             are eligible. Weight loss is recommended for overweight diabetic participants with one&#xD;
             or more cardiovascular risk factors.&#xD;
&#xD;
          -  Age: Individuals older than 21 years are eligible.&#xD;
&#xD;
          -  Ethnicity: All ethnic groups are eligible for the study.&#xD;
&#xD;
          -  Blood pressure: AMDIT will enroll individuals whose blood pressure is under at least&#xD;
             moderate control. For safety purposes, moderate control will be defined in this study&#xD;
             as systolic values under 160 mm/Hg and diastolic values under 100 mm/Hg. Individuals&#xD;
             whose blood pressure exceeds these levels during screening will be advised to seek&#xD;
             treatment and may be re-evaluated following initiation of antihypertensive treatment.&#xD;
&#xD;
          -  Glycemic control: AMDIT will enroll individuals whose HbA1c is between 7.5 and 10%.&#xD;
             Individuals whose HbA1c exceeds this level may require more urgent care and will be&#xD;
             told to seek treatment and may also be re-evaluated for inclusion.&#xD;
&#xD;
          -  Lipid control: Individuals with a fasting triglycerides concentration less than 500&#xD;
             mg/dl are eligible.&#xD;
&#xD;
          -  Willingness to participate: Participants must be willing to be randomized to either&#xD;
             Almased or the Lifestyle Intervention and to follow the protocol to which they have&#xD;
             been assigned. Individuals must be willing to modify their diet and their activity if&#xD;
             they are assigned to the Lifestyle Intervention.&#xD;
&#xD;
        Exclusion Criteria:• Unable or unwilling to give informed consent or communicate with local&#xD;
        study staff;&#xD;
&#xD;
          -  Psychotic disorders or bipolar disorders, hospitalization for depression in past six&#xD;
             months;&#xD;
&#xD;
          -  Self-report of alcohol or substance abuse within the past twelve months, current&#xD;
             consumption of more than 14 alcoholic drinks per week, and/or current acute treatment&#xD;
             or rehabilitation program for these problems;&#xD;
&#xD;
          -  Plans to relocate to an area not served by AMDIT or travel plans that do not permit&#xD;
             full participation in the study;&#xD;
&#xD;
          -  Known allergies to soy or dairy;&#xD;
&#xD;
          -  Current use of medications for weight loss;&#xD;
&#xD;
          -  Self-reported inability to walk two blocks;&#xD;
&#xD;
          -  History of bariatric surgery, small bowel resection, or extensive bowel resection;&#xD;
&#xD;
          -  Chronic treatment with systemic corticosteroids as weight gain associated with&#xD;
             steroids may interfere with the intervention goals;&#xD;
&#xD;
          -  Candidates who have definite plans to move out of the area within the study period;&#xD;
&#xD;
          -  Candidates with any dietary practice, behavior, or attitude that would substantially&#xD;
             limit adherence to the intervention;&#xD;
&#xD;
          -  Currently pregnant or nursing;&#xD;
&#xD;
          -  Cancer requiring treatment in the past five years, except for non-melanoma skin&#xD;
             cancers or cancers that have clearly been cured or in the opinion of the investigator&#xD;
             carry an excellent prognosis (e.g. Stage 1 cervical cancer);&#xD;
&#xD;
          -  HIV positive (self-report), due to effects on weight and body composition of HIV and&#xD;
             medications used to treat HIV;&#xD;
&#xD;
          -  Active tuberculosis (self-report);&#xD;
&#xD;
          -  Cardiovascular or cardiopulmonary disease including a heart attack or procedure within&#xD;
             the past three months; participation in a cardiac rehabilitation program within last&#xD;
             three months; stroke or history/treatment for transient ischemic attacks in the past&#xD;
             three months; documented history of pulmonary embolus in past six months; unstable&#xD;
             angina pectoris or angina pectoris at rest; known history of cardiac arrest; known&#xD;
             history of complex ventricular arrhythmia at rest or with exercise; known history of&#xD;
             uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more); known&#xD;
             history of NYHA Class III or IV congestive heart failure; known history of acute&#xD;
             myocarditis, pericarditis or hypertrophic myocardiopathy; known history of clinically&#xD;
             significant aortic stenosis; known history of left bundle branch block or cardiac&#xD;
             pacemaker unless evaluated by a cardiologist; cardiac defibrillator; heart transplant;&#xD;
             known history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm&#xD;
             repair;&#xD;
&#xD;
          -  Renal disease: urine dipstick protein of 4+ (equivalent to approximately &gt; 1 g/day),&#xD;
             serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently&#xD;
             receiving dialysis;&#xD;
&#xD;
          -  Known history of chronic obstructive pulmonary disease that would limit ability to&#xD;
             follow the protocol;&#xD;
&#xD;
          -  Self-reported chronic hepatitis B or C or cirrhosis;&#xD;
&#xD;
          -  Inflammatory bowel disease requiring treatment in the past year;&#xD;
&#xD;
          -  Known history of Cushing's syndrome (clinic diagnosis or self-report);&#xD;
&#xD;
          -  Known history of Acromegaly (clinical diagnosis or self-report);&#xD;
&#xD;
          -  Amputation of lower limbs as result of non-traumatic causes;&#xD;
&#xD;
          -  Any major organ transplant (does not include cornea or hair transplants);&#xD;
&#xD;
          -  Conditions not specifically mentioned above may serve as criteria for exclusion at the&#xD;
             discretion of the clinical site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mara Z Vitolins, DrPH MPH RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes-Obesity</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01702012
org study id: IRB00020672
nct id: NCT01702012
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 12 month multi-center randomization controlled study. Participants will be randomized to
      either a lifestyle education program or a meal replacement regimen with Almased, after an
      initial examination of eligibility criteria.

      Primary outcome-HbA1c
Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c
      7.5-10%
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in HbA1c (%)
time frame: 2, 4, 6, 8, 10, and 12 months
measure: Change in HOMA IR Index
time frame: 2, 4, 6, 8, 10, and 12 months
description: measure changes in Homeostasis Model of Insulin Resistance
measure: Change in fasting blood glucose (mg/dl)
time frame: 2, 4, 6, 8, 10, and 12 months
arm group label: Almased Meal Replacement Powder
arm group type: Experimental
description: Participants assigned to this arm will receive the Almased meal replacement powder and will be asked to replace one meal per day during the first 6 months of participation. During the second 6 months, participants will be allowed to choose whether to continue using the product to replace a meal or to use the product as a supplement prior to meals.
arm group label: Lifestyle Intervention
arm group type: Active Comparator
description: Participants randomized to this group will receive 5 group sessions in the first two months of participation and 5 additional group sessions in the last two months. These group sessions will focus on lifestyle behavior changes for weight loss and management including goal-setting, calorie balance, general nutrition, and physical activity.
intervention type: Dietary Supplement
intervention name: Almased Meal Replacement Powder
description: Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals.
arm group label: Almased Meal Replacement Powder
intervention type: Behavioral
intervention name: Group-Based Lifestyle Intervention
arm group label: Lifestyle Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mara Z Vitolins, DrPH MPH RD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No