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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Hypertension

Intervention / Treatment
-----------------
* Drug: Phentermine and B12
* Drug: Phentermine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phentermine and B12<br>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<br> <br> * Other names: Adipex-P, Cyanocobalamin;|
| Active Comparator: Phentermine<br>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<br> <br> * 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 |