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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
Information provided by (Responsible Party):
Dr. Michael Lang, East Carolina University

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.

Condition or disease Intervention/treatment Phase
Obesity Hypertension Drug: Phentermine and B12 Drug: Phentermine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Phentermine and B12
Other Name: Adipex-P, Cyanocobalamin

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.
Drug: Phentermine
Other Name: Adipex- P

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Waist Circumference [ Time Frame: 24 weeks ]
    Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719185

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United States, North Carolina
Brody Outpatient of Brody Medical Sciences Module D
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Dr. Michael Lang
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Principal Investigator: Michael C Lang, MD ECU Physicians General Internal Medicine, Psychiatry
Study Chair: James Powell, MD ECU Physicians General Internal Medicine
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Responsible Party: Dr. Michael Lang, Michael Lang, MD, Internal Medicine, Psychiatrics, East Carolina University
ClinicalTrials.gov Identifier: NCT01719185    
Other Study ID Numbers: 12-001323
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Vitamin B 12
Central Nervous System Stimulants
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex