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

A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity
• Intervention / Treatment: Drug: Phentermine and B12; Drug: Phentermine

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: Interventional
• Enrollment (Actual): 22
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Brody Outpatient of Brody Medical Sciences Module D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Adipex- P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.	24 weeks (6 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Michael Lang
• Investigators: Principal Investigator: Michael C Lang, MD, ECU Physicians General Internal Medicine, Psychiatry; Study Chair: James Powell, MD, ECU Physicians General Internal Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Micronutrients; Vitamins; Appetite Depressants; Anti-Obesity Agents; Vitamin B Complex; Central Nervous System Stimulants; Sympathomimetics; Vitamin B 12; Phentermine
• Other Study ID Numbers: 12-001323