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The Effect of Phentermine and B12 on Weight Loss Among Obese Patients

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ClinicalTrials.gov Identifier: NCT01719185
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Michael Lang, East Carolina University

Tracking Information
First Submitted Date  ICMJE October 30, 2012
First Posted Date  ICMJE November 1, 2012
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
Weight Change [ Time Frame: 24 weeks (6 months) ]
Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • Blood Pressure [ Time Frame: 24 weeks ]
    Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.
  • Waist Circumference [ Time Frame: 24 weeks ]
    Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
  • Waist to hip ratio [ Time Frame: 24 weeks ]
    Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
Official Title  ICMJE A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Hypertension
Intervention  ICMJE
  • Drug: Phentermine and B12
    Other Name: Adipex-P, Cyanocobalamin
  • Drug: Phentermine
    Other Name: Adipex- P
Study Arms  ICMJE
  • Experimental: Phentermine and B12
    Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly.
    Intervention: Drug: Phentermine and B12
  • Active Comparator: Phentermine
    Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.
    Intervention: Drug: Phentermine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2012)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Individuals can participate in the study if they meet the following inclusion criteria:

  • Are over the age of 18
  • Have a BMI between 30 and 40
  • Have a controlled blood pressure
  • Do not have a B12 deficiency
  • Are willing to take birth control (if female and not sterile or through menopause)
  • Are English speaking

Individuals should not participate in if any of the following apply to them:

  • Are not over the age of 18
  • Do not have a BMI between 30 and 40
  • Do not have a controlled blood pressure
  • Have a B12 deficiency
  • Females who are pregnant, trying to get pregnant, or not willing to use a method of birth control to ensure they do not become pregnant
  • Individuals who do not speak English
  • Individuals currently taking Adderall, Ritalin, or any other stimulant medication
  • Individuals who have taken phentermine more than once in the past, or within 3 months of study initiation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01719185
Other Study ID Numbers  ICMJE 12-001323
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Michael Lang, East Carolina University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr. Michael Lang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael C Lang, MD ECU Physicians General Internal Medicine, Psychiatry
Study Chair: James Powell, MD ECU Physicians General Internal Medicine
PRS Account East Carolina University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP