The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
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.
Drug: Phentermine and B12
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Weight Change [ Time Frame: 24 weeks (6 months) ] [ Designated as safety issue: No ]Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.
- Blood Pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
Other Name: Adipex- P
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719185
|United States, North Carolina|
|Brody Outpatient of Brody Medical Sciences Module D|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Michael C Lang, MD||ECU Physicians General Internal Medicine, Psychiatry|
|Study Chair:||James Powell, MD||ECU Physicians General Internal Medicine|