<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/NCT01719185</url>
  </required_header>
  <id_info>
    <org_study_id>12-001323</org_study_id>
    <nct_id>NCT01719185</nct_id>
  </id_info>
  <brief_title>The Effect of Phentermine and B12 on Weight Loss Among Obese Patients</brief_title>
  <official_title>A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Michael Lang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>East Carolina University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study designed to test the hypothesis that the combination of phentermine and&#xD;
      B12 will result in significantly greater weight loss among obese patients compared to&#xD;
      phentermine alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a double blind, randomized controlled trial designed to determine the&#xD;
      significance of the combination therapy of phentermine and B12 injections among the obese&#xD;
      population. The study population will be recruited from the ECU Physicians Internal Medicine&#xD;
      clinic. Physicians will select patients meeting inclusion and exclusion criteria from their&#xD;
      clinic to be approached for recruitment. Approximately 30 patients will be recruited and&#xD;
      blindly randomized to either the treatment group (phentermine and B12 in combination) or the&#xD;
      control group (phentermine alone). Patients will be randomized by means of block&#xD;
      randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group&#xD;
      assignments through the entire duration of the study. Once randomized, both groups will begin&#xD;
      taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections&#xD;
      of either 1000 mg B12 or Saline depending on their group assignment. The study will consist&#xD;
      of approximately 15 visits over the course of 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Change</measure>
    <time_frame>24 weeks (6 months)</time_frame>
    <description>Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>24 weeks</time_frame>
    <description>Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>24 weeks</time_frame>
    <description>Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist to hip ratio</measure>
    <time_frame>24 weeks</time_frame>
    <description>Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Obesity</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Phentermine and B12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phentermine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phentermine and B12</intervention_name>
    <arm_group_label>Phentermine and B12</arm_group_label>
    <other_name>Adipex-P, Cyanocobalamin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phentermine</intervention_name>
    <arm_group_label>Phentermine</arm_group_label>
    <other_name>Adipex- P</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Individuals can participate in the study if they meet the following inclusion criteria:&#xD;
&#xD;
          -  Are over the age of 18&#xD;
&#xD;
          -  Have a BMI between 30 and 40&#xD;
&#xD;
          -  Have a controlled blood pressure&#xD;
&#xD;
          -  Do not have a B12 deficiency&#xD;
&#xD;
          -  Are willing to take birth control (if female and not sterile or through menopause)&#xD;
&#xD;
          -  Are English speaking&#xD;
&#xD;
        Individuals should not participate in if any of the following apply to them:&#xD;
&#xD;
          -  Are not over the age of 18&#xD;
&#xD;
          -  Do not have a BMI between 30 and 40&#xD;
&#xD;
          -  Do not have a controlled blood pressure&#xD;
&#xD;
          -  Have a B12 deficiency&#xD;
&#xD;
          -  Females who are pregnant, trying to get pregnant, or not willing to use a method of&#xD;
             birth control to ensure they do not become pregnant&#xD;
&#xD;
          -  Individuals who do not speak English&#xD;
&#xD;
          -  Individuals currently taking Adderall, Ritalin, or any other stimulant medication&#xD;
&#xD;
          -  Individuals who have taken phentermine more than once in the past, or within 3 months&#xD;
             of study initiation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael C Lang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECU Physicians General Internal Medicine, Psychiatry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Powell, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ECU Physicians General Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brody Outpatient of Brody Medical Sciences Module D</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>August 11, 2015</last_update_submitted>
  <last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>East Carolina University</investigator_affiliation>
    <investigator_full_name>Dr. Michael Lang</investigator_full_name>
    <investigator_title>Michael Lang, MD, Internal Medicine, Psychiatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin B 12</mesh_term>
    <mesh_term>Phentermine</mesh_term>
  </intervention_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/NCT01719185
org study id: 12-001323
nct id: NCT01719185
lead sponsor: 
has dmc: Yes
This is a pilot study designed to test the hypothesis that the combination of phentermine and
      B12 will result in significantly greater weight loss among obese patients compared to
      phentermine alone.
This pilot study is a double blind, randomized controlled trial designed to determine the
      significance of the combination therapy of phentermine and B12 injections among the obese
      population. The study population will be recruited from the ECU Physicians Internal Medicine
      clinic. Physicians will select patients meeting inclusion and exclusion criteria from their
      clinic to be approached for recruitment. Approximately 30 patients will be recruited and
      blindly randomized to either the treatment group (phentermine and B12 in combination) or the
      control group (phentermine alone). Patients will be randomized by means of block
      randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group
      assignments through the entire duration of the study. Once randomized, both groups will begin
      taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections
      of either 1000 mg B12 or Saline depending on their group assignment. The study will consist
      of approximately 15 visits over the course of 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Weight Change
time frame: 24 weeks (6 months)
description: Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.
measure: Blood Pressure
time frame: 24 weeks
description: Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.
measure: Waist Circumference
time frame: 24 weeks
description: Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
measure: Waist to hip ratio
time frame: 24 weeks
description: Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.
arm group label: Phentermine and B12
arm group type: Experimental
description: Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly.
arm group label: Phentermine
arm group type: Active Comparator
description: Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.
intervention type: Drug
intervention name: Phentermine and B12
arm group label: Phentermine and B12
other name: Adipex-P, Cyanocobalamin
intervention type: Drug
intervention name: Phentermine
arm group label: Phentermine
other name: Adipex- P
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael C Lang, MD
role: Principal Investigator
affiliation: ECU Physicians General Internal Medicine, Psychiatry
last name: James Powell, MD
role: Study Chair
affiliation: ECU Physicians General Internal Medicine
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: East Carolina University
investigator full name: Dr. Michael Lang
investigator title: Michael Lang, MD, Internal Medicine, Psychiatrics
mesh term: Weight Loss
mesh term: Vitamin B 12
mesh term: Phentermine