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

Early Phase 1

Completed

• Conditions: Obesity; Hypertension
• Interventions: Drug: Phentermine and B12; Drug: Phentermine

• Registration Number: NCT01719185
• Lead Sponsor: Dr. Michael Lang

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phentermine and B12	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.
Phentermine	Phentermine	Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.

Primary Outcome Measures

Name	Time	Method
Weight Change	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

Name	Time	Method
Blood Pressure	24 weeks	Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.
Waist Circumference	24 weeks	Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
Waist to hip ratio	24 weeks	Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.

Trial Locations

Locations (1)

Brody Outpatient of Brody Medical Sciences Module D; 🇺🇸 Greenville, North Carolina, United States