Clinical trial NCT01719185: The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Hypertension
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Change
timeFrame: 24 weeks (6 months)
Secondary outcomes:
measure: Blood Pressure
timeFrame: 24 weeks
measure: Waist Circumference
timeFrame: 24 weeks
measure: Waist to hip ratio
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Brody Outpatient of Brody Medical Sciences Module D
state: North Carolina
Study officials:
affiliation: ECU Physicians General Internal Medicine, Psychiatry
name: Michael C Lang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ECU Physicians General Internal Medicine
name: James Powell, MD
role: STUDY_CHAIR
References: