<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/NCT01667783</url>
  </required_header>
  <id_info>
    <org_study_id>DK089557</org_study_id>
    <secondary_id>R01DK089557</secondary_id>
    <nct_id>NCT01667783</nct_id>
  </id_info>
  <brief_title>Improving Diabetes Through Lifestyle and Surgery</brief_title>
  <acronym>IDeaLS</acronym>
  <official_title>Improving Diabetes Through Lifestyle and Surgery Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight loss is effective in reducing many complications of obesity, with the majority of&#xD;
      patients who undergo bariatric surgery having substantial improvements in their&#xD;
      weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to&#xD;
      moderate obesity to compare how losing 10% of initial body weight via one of three common&#xD;
      weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass&#xD;
      surgery, and adjustable gastric banding) affects diabetes. While the investigators do not&#xD;
      expect this pilot study to provide definitive answers, it will provide valuable information&#xD;
      to design a larger trial which will help guide therapy for people with mild-moderate obesity&#xD;
      and substantial comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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 HbA1c from baseline to final data collection</measure>
    <time_frame>Average time 6 months</time_frame>
    <description>Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in insulin secretion</measure>
    <time_frame>Average time 6 months</time_frame>
    <description>Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Obesity</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Gastric Banding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic Adjustable Gastric Banding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Weight Loss</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric Bypass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux-en-Y Gastric Bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric Banding</intervention_name>
    <description>Laparoscopic Adjustable Gastric Banding using the LapBand</description>
    <arm_group_label>Gastric Banding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical Weight Loss</intervention_name>
    <description>Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians</description>
    <arm_group_label>Medical Weight Loss</arm_group_label>
    <other_name>HMR meal replacements will be used</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric Bypass</intervention_name>
    <description>Laparoscopic Roux-en-Y Gastric Bypass</description>
    <arm_group_label>Gastric Bypass</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 30-40 kg/m2 at screening visit 1&#xD;
&#xD;
          -  Age 21-64 years&#xD;
&#xD;
          -  Insured by collaborating insurance plan (Employee Health Plan)&#xD;
&#xD;
          -  Type 2 Diabetes&#xD;
&#xD;
          -  Medically safe to undergo surgery and approved by a psychologist&#xD;
&#xD;
          -  Able to exercise at a moderate level&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Willing to accept randomization to each group&#xD;
&#xD;
          -  Able to communicate (both written and oral) in English&#xD;
&#xD;
          -  Willing to use reliable method of birth control during study and ≥18 months postop (if&#xD;
             applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior bariatric surgery&#xD;
&#xD;
          -  Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery,&#xD;
             including large ventral hernia or previous large ventral hernia repair.&#xD;
&#xD;
          -  Weight loss of ≥ 5% of body weight in the past 6 months&#xD;
&#xD;
          -  Uncontrolled diabetes (HbA1c&gt;8.5%)&#xD;
&#xD;
          -  Untreated severe diabetic retinopathy&#xD;
&#xD;
          -  Use of thiazolidinediones or insulin currently or within the past 3 months&#xD;
&#xD;
          -  Uncontrolled blood pressure (&gt;160/100 -may be rescreened)&#xD;
&#xD;
          -  Estimated glomerular filtration rate (GFR)&lt;30&#xD;
&#xD;
          -  Malignancy (except squamous or basal cell of the skin) in the past 5 years&#xD;
&#xD;
          -  MI, stroke or cardiovascular procedure within 12 months&#xD;
&#xD;
          -  Known HIV positive or use of anti-HIV therapy (HAART)&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Significant pulmonary disease with oxygen dependency&#xD;
&#xD;
          -  Chronic use (including in the past 6 months) of medications likely to cause weight&#xD;
             gain or prevent weight loss (e.g. corticosteroids, lithium)&#xD;
&#xD;
          -  Use of prescription weight loss medication or over-the-counter orlistat in the past 6&#xD;
             months&#xD;
&#xD;
          -  Other serious medical condition likely to hinder accurate measurement of weight, or&#xD;
             for which weight loss is contraindicated, or which would cause weight loss&#xD;
&#xD;
          -  History of severe depression requiring hospitalization in the past 12 months&#xD;
&#xD;
          -  Severe mental illness including bipolar disorder, schizophrenia or other psychotic&#xD;
             disorders&#xD;
&#xD;
          -  Current bulimia nervosa&#xD;
&#xD;
          -  Unable or unwilling to use meal replacement products&#xD;
&#xD;
          -  Consumption of &gt;14 alcoholic drinks/week or &gt; 5 drinks on more than 2 occasions in the&#xD;
             past 12 months&#xD;
&#xD;
          -  Use of illicit substances in the past 12 months&#xD;
&#xD;
          -  Cigarette or cigar smoking in the past 2 months&#xD;
&#xD;
          -  Pregnant or nursing within past 6 months&#xD;
&#xD;
          -  Plans to become pregnant within 2 years&#xD;
&#xD;
          -  Plans to relocate from the area within 1 year&#xD;
&#xD;
          -  Another member of household is a study participant or staff in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanne M. Clark, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>May 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Dr. Jeanne Clark</investigator_full_name>
    <investigator_title>Principal Investigator, Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01667783
org study id: DK089557
secondary id: R01DK089557
nct id: NCT01667783
lead sponsor: 
collaborator: 
has dmc: Yes
Weight loss is effective in reducing many complications of obesity, with the majority of
      patients who undergo bariatric surgery having substantial improvements in their
      weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to
      moderate obesity to compare how losing 10% of initial body weight via one of three common
      weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass
      surgery, and adjustable gastric banding) affects diabetes. While the investigators do not
      expect this pilot study to provide definitive answers, it will provide valuable information
      to design a larger trial which will help guide therapy for people with mild-moderate obesity
      and substantial comorbidities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c from baseline to final data collection
time frame: Average time 6 months
description: Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.
measure: Change in insulin secretion
time frame: Average time 6 months
description: Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.
arm group label: Gastric Banding
arm group type: Active Comparator
description: Laparoscopic Adjustable Gastric Banding
arm group label: Medical Weight Loss
arm group type: Active Comparator
description: Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques
arm group label: Gastric Bypass
arm group type: Active Comparator
description: Roux-en-Y Gastric Bypass
intervention type: Procedure
intervention name: Gastric Banding
description: Laparoscopic Adjustable Gastric Banding using the LapBand
arm group label: Gastric Banding
intervention type: Behavioral
intervention name: Medical Weight Loss
description: Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
arm group label: Medical Weight Loss
other name: HMR meal replacements will be used
intervention type: Procedure
intervention name: Gastric Bypass
description: Laparoscopic Roux-en-Y Gastric Bypass
arm group label: Gastric Bypass
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: No
last name: Jeanne M. Clark, MD, MPH
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Dr. Jeanne Clark
investigator title: Principal Investigator, Associate Professor of Medicine
mesh term: Diabetes Mellitus