xml: <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/NCT05975580</url>
    </required_header>
    <id_info>
      <org_study_id>1849</org_study_id>
      <secondary_id>R01DK129936</secondary_id>
      <nct_id>NCT05975580</nct_id>
    </id_info>
    <brief_title>Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery</brief_title>
    <acronym>PROJECT-BARI</acronym>
    <official_title>Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Irvine</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>University of California, Irvine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized&#xD;
        Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle&#xD;
        counseling, can reverse weight regain after bariatric surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Although bariatric surgery is the most effective treatment for severe obesity, a large&#xD;
        proportion of patients experience significant weight regain with longer follow-up.&#xD;
  &#xD;
        In this randomized controlled trial employing a SMART design, a total of 120 subjects with&#xD;
        weight regain after bariatric surgery, will be initially randomized in a 3:3:2 ratio to daily&#xD;
        treatment with topiramate (TPM) 50 mg or phentermine (PHEN) 7.5 mg or placebo. After 4&#xD;
        months, responders (those with ≥5% weight loss) will continue the same treatment, while&#xD;
        nonresponders will be re-randomized to a higher dose of the same drug or&#xD;
        phentermine/topiramate 7.5/50 mg combination (PHEN/TPM) during Months 5-12. All subjects will&#xD;
        receive diet and lifestyle counseling throughout the study.&#xD;
  &#xD;
        Aim 1: To determine whether pharmacotherapy can reverse post-bariatric surgery weight regain.&#xD;
  &#xD;
        Hypothesis: Compared to placebo, all three active drug therapies - TPM, PHEN, and PHEN/TPM&#xD;
        will lead to greater percent weight loss at Month 12.&#xD;
  &#xD;
        Aim 2: To examine change in energy intake assessed by a dietitian interview.&#xD;
  &#xD;
        Hypothesis: Compared to placebo, active drug therapies will lead to greater reduction in&#xD;
        energy intake at Month 12.&#xD;
  &#xD;
        Aim 3: To examine changes in the most common maladaptive eating behaviors in the&#xD;
        post-bariatric surgery patients - grazing, loss-of-control eating, and binge eating.&#xD;
  &#xD;
        Hypothesis: Compared to placebo, active drug therapies will lead to decreased maladaptive&#xD;
        eating behaviors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 2, 2027</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>A total of 120 eligible subjects, with weight regain after bariatric surgery, will be initially randomized in a 3:3:2 ratio to daily treatment with topiramate (TPM) 50 mg or phentermine (PHEN) 7.5 mg or placebo. After 4 months, responders (those with ≥5% weight loss) will continue the same treatment, while nonresponders will be re-randomized to a higher dose of the same drug or phentermine/topiramate 7.5/50 mg combination (PHEN/TPM) during Months 5-12. All randomized subjects will receive lifestyle counseling throughout the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The investigational drugs and placebo capsules will look identical. University of California Irvine Medical Center Investigational Drug Service will dispense the masked study drugs in accordance with randomization. The study statistician who generates the randomization scheme and the research pharmacist who dispenses the study drugs are the only personnel who are unblinded to the randomized assignment. Investigators and all other study personnel and the study subjects will be blinded to the treatment assignment until subjects have completed all visits, all data have been entered, and the data file has been locked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percent weight loss at Month 12 - Topiramate vs placebo</measure>
      <time_frame>Month 0, Month 12</time_frame>
      <description>Topiramate (Group 1 [Group A + Group B]) vs placebo (Group P)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent weight loss at Month 12 - Phentermine vs placebo</measure>
      <time_frame>Month 0, Month 12</time_frame>
      <description>Phentermine (Group 2 [Group D + Group E) vs placebo (Group P)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent weight loss at Month 12 - Phentermine/Topiramate</measure>
      <time_frame>Month 0, Month 12</time_frame>
      <description>Phentermine/Topiramate (Group 3 [Group C + Group F]) vs placebo (Group P)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Energy intake</measure>
      <time_frame>Month 0, Month 12</time_frame>
      <description>Change in energy intake in kcal/d assessed with a dietitian interview. Comparisons between Groups 1, 2, 3 vs placebo.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Grazing</measure>
      <time_frame>Months 0, 4, 12</time_frame>
      <description>Change in grazing behavior, assessed with the Grazing Questionnaire. Comparisons between Groups 1, 2, 3 vs placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Loss-of-control eating</measure>
      <time_frame>Months 0, 4, 12</time_frame>
      <description>Change in loss-of-control eating, assessed with the Loss-of-Control Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.</description>
    </other_outcome>
    <other_outcome>
      <measure>Binge eating</measure>
      <time_frame>Months 0, 4, 12</time_frame>
      <description>Change in binge eating, assessed with the Binge Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.</description>
    </other_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Group A: Topiramate 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topiramate will be started at 25 mg daily and the dose will be increased to 50 mg daily after 15 days. Responders at Month 4 will continue the same treatment until Month 12.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Topiramate 100 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group D: Phentermine 7.5 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phentermine will be started at 7.5 mg daily. Responders at Month 4 will continue the same treatment until Month 12.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group E: Phentermine 15 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group F: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12. For Group F, topiramate will be dosed at 25 mg daily for the 15 days in Month 5 and 50 mg daily thereafter,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group P: Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo group will receive placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topiramate</intervention_name>
      <description>Topiramate is an anticonvulsant (antiepilepsy) drug. IUPAC ID: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate</description>
      <arm_group_label>Group A: Topiramate 50 mg</arm_group_label>
      <arm_group_label>Group B: Topiramate 100 mg</arm_group_label>
      <arm_group_label>Group C: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
      <arm_group_label>Group F: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Phentermine</intervention_name>
      <description>Phentermine belongs to a class of drugs called anorectics, also known as appetite suppressants. IUPAC name 2-methyl-1-phenylpropan-2-amine</description>
      <arm_group_label>Group C: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
      <arm_group_label>Group D: Phentermine 7.5 mg</arm_group_label>
      <arm_group_label>Group E: Phentermine 15 mg</arm_group_label>
      <arm_group_label>Group F: Phentermine 7.5 mg/Topiramate 50 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo is an inactive substance.</description>
      <arm_group_label>Group P: Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female subjects aged 18-70 years&#xD;
  &#xD;
            2. Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) between ≥18 months and&#xD;
               ≤10 years ago&#xD;
  &#xD;
            3. Weight regain of ≥5% relative to post-surgery nadir weight&#xD;
  &#xD;
            4. Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities&#xD;
  &#xD;
            5. Women of childbearing potential must be using appropriate contraception to avoid&#xD;
               pregnancy throughout the study, and must have a negative pregnancy test at study entry&#xD;
  &#xD;
            6. Must be able to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Type 1 diabetes&#xD;
  &#xD;
            2. Insulin-dependent type 2 diabetes&#xD;
  &#xD;
            3. Fasting plasma glucose (FPG) ≥240 mg/dL&#xD;
  &#xD;
            4. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or&#xD;
               diastolic blood pressure (DBP) ≥100 mm Hg on the average of three seated measurements&#xD;
               after being at rest for at least 5 minutes&#xD;
  &#xD;
            5. History of significant (as determined by the investigator) and unstable cardiovascular&#xD;
               disease including coronary artery disease, arrhythmias, severe congestive heart&#xD;
               failure, or stroke&#xD;
  &#xD;
            6. Use of monoamine oxidase inhibitors, current or within 2 weeks&#xD;
  &#xD;
            7. Hyperthyroidism or other significant thyroid disease&#xD;
  &#xD;
            8. Angle-closure glaucoma&#xD;
  &#xD;
            9. Agitated states&#xD;
  &#xD;
           10. History of drug abuse within the past year&#xD;
  &#xD;
           11. Known hypersensitivity or idiosyncrasy to sympathomimetic amines&#xD;
  &#xD;
           12. Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic&#xD;
               steatohepatitis without portal hypertension or cirrhosis is acceptable)&#xD;
  &#xD;
           13. End-stage renal disease&#xD;
  &#xD;
           14. History of nephrolithiasis&#xD;
  &#xD;
           15. Serum triglycerides ≥500 mg/dL&#xD;
  &#xD;
           16. Cancer, not in remission, within the past 2 years except for adequately treated basal&#xD;
               cell, squamous cell skin cancer, or in-situ cervical cancer&#xD;
  &#xD;
           17. History of psychosis or bipolar disorder&#xD;
  &#xD;
           18. Suicidal ideation or unstable/untreated major depressive disorder within the past year&#xD;
  &#xD;
           19. Use of antidepressant medication that has not been at stable dose for at least 3&#xD;
               months&#xD;
  &#xD;
           20. Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety&#xD;
               items&#xD;
  &#xD;
           21. Binge Eating Scale (BES) score of ≥27&#xD;
  &#xD;
           22. Alcohol use disorder within the past year&#xD;
  &#xD;
           23. Epilepsy&#xD;
  &#xD;
           24. Currently taking phentermine or topiramate or the combination, or products containing&#xD;
               these drugs&#xD;
  &#xD;
           25. Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder&#xD;
               medications)&#xD;
  &#xD;
           26. Current use of prescription or over-the-counter weight loss drugs or supplements&#xD;
  &#xD;
           27. Taking prescription or over-the-counter drugs or products, which in the opinion of the&#xD;
               PI, could be associated with significant effects on body weight&#xD;
  &#xD;
           28. Planning additional bariatric surgery procedures in the next 13 months&#xD;
  &#xD;
           29. History of revisional bariatric surgery (revisional surgery after adjustable gastric&#xD;
               banding is acceptable)&#xD;
  &#xD;
           30. Currently participating in another weight loss program or have plans to participate in&#xD;
               the next 13 months&#xD;
  &#xD;
           31. Smoking cessation within the previous 3 months or plans to quit smoking in the next 13&#xD;
               months&#xD;
  &#xD;
           32. Pregnant or breastfeeding or planning pregnancy in the coming 13 months&#xD;
  &#xD;
           33. History of, or any existing condition that, in the opinion of the Principal&#xD;
               Investigator, would interfere with the study outcomes or place the subject at&#xD;
               unacceptable risk by participating in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kishore M Gadde, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Irvine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Phuong Linh Huynh, MPH</last_name>
      <phone>7144566155</phone>
      <email>plhuynh@hs.uci.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qin Wang</last_name>
      <email>qinw15@hs.uci.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California Irvine Medical Center</name>
        <address>
          <city>Orange</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Phuong Linh Huynh, MPH</last_name>
        <phone>714-456-6155</phone>
        <email>plhuynh@hs.uci.edu</email>
      </contact>
      <contact_backup>
        <last_name>Qin Wang</last_name>
        <email>qinw15@hs.uci.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Kishore M Gadde, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.</citation>
      <PMID>36752995</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Irvine</investigator_affiliation>
      <investigator_full_name>Kishore M Gadde, MD</investigator_full_name>
      <investigator_title>Professor In Residence, Surgery</investigator_title>
    </responsible_party>
    <keyword>Bariatric surgery</keyword>
    <keyword>Weight regain</keyword>
    <keyword>Antiobesity drugs</keyword>
    <keyword>Treatment of weight regain</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Topiramate</mesh_term>
      <mesh_term>Phentermine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975580
  org study id: 1849
  secondary id: R01DK129936
  nct id: NCT05975580
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized
        Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle
        counseling, can reverse weight regain after bariatric surgery.
  Although bariatric surgery is the most effective treatment for severe obesity, a large
        proportion of patients experience significant weight regain with longer follow-up.
  
        In this randomized controlled trial employing a SMART design, a total of 120 subjects with
        weight regain after bariatric surgery, will be initially randomized in a 3:3:2 ratio to daily
        treatment with topiramate (TPM) 50 mg or phentermine (PHEN) 7.5 mg or placebo. After 4
        months, responders (those with ≥5% weight loss) will continue the same treatment, while
        nonresponders will be re-randomized to a higher dose of the same drug or
        phentermine/topiramate 7.5/50 mg combination (PHEN/TPM) during Months 5-12. All subjects will
        receive diet and lifestyle counseling throughout the study.
  
        Aim 1: To determine whether pharmacotherapy can reverse post-bariatric surgery weight regain.
  
        Hypothesis: Compared to placebo, all three active drug therapies - TPM, PHEN, and PHEN/TPM
        will lead to greater percent weight loss at Month 12.
  
        Aim 2: To examine change in energy intake assessed by a dietitian interview.
  
        Hypothesis: Compared to placebo, active drug therapies will lead to greater reduction in
        energy intake at Month 12.
  
        Aim 3: To examine changes in the most common maladaptive eating behaviors in the
        post-bariatric surgery patients - grazing, loss-of-control eating, and binge eating.
  
        Hypothesis: Compared to placebo, active drug therapies will lead to decreased maladaptive
        eating behaviors.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: A total of 120 eligible subjects, with weight regain after bariatric surgery, will be initially randomized in a 3:3:2 ratio to daily treatment with topiramate (TPM) 50 mg or phentermine (PHEN) 7.5 mg or placebo. After 4 months, responders (those with ≥5% weight loss) will continue the same treatment, while nonresponders will be re-randomized to a higher dose of the same drug or phentermine/topiramate 7.5/50 mg combination (PHEN/TPM) during Months 5-12. All randomized subjects will receive lifestyle counseling throughout the study.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The investigational drugs and placebo capsules will look identical. University of California Irvine Medical Center Investigational Drug Service will dispense the masked study drugs in accordance with randomization. The study statistician who generates the randomization scheme and the research pharmacist who dispenses the study drugs are the only personnel who are unblinded to the randomized assignment. Investigators and all other study personnel and the study subjects will be blinded to the treatment assignment until subjects have completed all visits, all data have been entered, and the data file has been locked.
  measure: Percent weight loss at Month 12 - Topiramate vs placebo
  time frame: Month 0, Month 12
  description: Topiramate (Group 1 [Group A + Group B]) vs placebo (Group P)
  measure: Percent weight loss at Month 12 - Phentermine vs placebo
  time frame: Month 0, Month 12
  description: Phentermine (Group 2 [Group D + Group E) vs placebo (Group P)
  measure: Percent weight loss at Month 12 - Phentermine/Topiramate
  time frame: Month 0, Month 12
  description: Phentermine/Topiramate (Group 3 [Group C + Group F]) vs placebo (Group P)
  measure: Energy intake
  time frame: Month 0, Month 12
  description: Change in energy intake in kcal/d assessed with a dietitian interview. Comparisons between Groups 1, 2, 3 vs placebo.
  measure: Grazing
  time frame: Months 0, 4, 12
  description: Change in grazing behavior, assessed with the Grazing Questionnaire. Comparisons between Groups 1, 2, 3 vs placebo.
  measure: Loss-of-control eating
  time frame: Months 0, 4, 12
  description: Change in loss-of-control eating, assessed with the Loss-of-Control Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.
  measure: Binge eating
  time frame: Months 0, 4, 12
  description: Change in binge eating, assessed with the Binge Eating Scale. Comparisons between Groups 1, 2, 3 vs placebo.
  arm group label: Group A: Topiramate 50 mg
  arm group type: Experimental
  description: Topiramate will be started at 25 mg daily and the dose will be increased to 50 mg daily after 15 days. Responders at Month 4 will continue the same treatment until Month 12.
  arm group label: Group B: Topiramate 100 mg
  arm group type: Experimental
  description: Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
  arm group label: Group C: Phentermine 7.5 mg/Topiramate 50 mg
  arm group type: Experimental
  description: Nonresponders in the topiramate group at Month 4 will be re-randomized in a 1:1 ratio to receive topiramate 100 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
  arm group label: Group D: Phentermine 7.5 mg
  arm group type: Experimental
  description: Phentermine will be started at 7.5 mg daily. Responders at Month 4 will continue the same treatment until Month 12.
  arm group label: Group E: Phentermine 15 mg
  arm group type: Experimental
  description: Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12.
  arm group label: Group F: Phentermine 7.5 mg/Topiramate 50 mg
  arm group type: Experimental
  description: Nonresponders in the phentermine group at Month 4 will be re-randomized in a 1:1 ratio to receive phentermine 15 mg or phentermine/topiramate 7.5/50 mg during Months 5-12. For Group F, topiramate will be dosed at 25 mg daily for the 15 days in Month 5 and 50 mg daily thereafter,
  arm group label: Group P: Placebo
  arm group type: Placebo Comparator
  description: Placebo group will receive placebo.
  intervention type: Drug
  intervention name: Topiramate
  description: Topiramate is an anticonvulsant (antiepilepsy) drug. IUPAC ID: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
  arm group label: Group A: Topiramate 50 mg
  arm group label: Group B: Topiramate 100 mg
  arm group label: Group C: Phentermine 7.5 mg/Topiramate 50 mg
  arm group label: Group F: Phentermine 7.5 mg/Topiramate 50 mg
  intervention type: Drug
  intervention name: Phentermine
  description: Phentermine belongs to a class of drugs called anorectics, also known as appetite suppressants. IUPAC name 2-methyl-1-phenylpropan-2-amine
  arm group label: Group C: Phentermine 7.5 mg/Topiramate 50 mg
  arm group label: Group D: Phentermine 7.5 mg
  arm group label: Group E: Phentermine 15 mg
  arm group label: Group F: Phentermine 7.5 mg/Topiramate 50 mg
  intervention type: Drug
  intervention name: Placebo
  description: Placebo is an inactive substance.
  arm group label: Group P: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Kishore M Gadde, MD
  role: Principal Investigator
  affiliation: University of California, Irvine
  last name: Phuong Linh Huynh, MPH
  phone: 7144566155
  email: plhuynh@hs.uci.edu
  last name: Qin Wang
  email: qinw15@hs.uci.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.
  PMID: 36752995
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Irvine
  investigator full name: Kishore M Gadde, MD
  investigator title: Professor In Residence, Surgery
  mesh term: Topiramate
  mesh term: Phentermine
  sharing ipd: No