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

• ClinicalTrials.gov Identifier: NCT01719185
• Recruitment Status: Completed
• First Posted: November 1, 2012
• Last Update Posted: August 13, 2015
• Sponsor: Dr. Michael Lang
• Information provided by (Responsible Party): Dr. Michael Lang, East Carolina University

Tracking Information

• First Submitted Date: October 30, 2012
• First Posted Date: November 1, 2012
• Last Update Posted Date: August 13, 2015
• Study Start Date: September 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2012)

Weight Change [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 30, 2012)

• Blood Pressure [ Time Frame: 24 weeks ]
  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 ]
  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 ]
  Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Obesity
• Hypertension

Intervention

• Drug: Phentermine and B12
  Other Name: Adipex-P, Cyanocobalamin
• Drug: Phentermine
  Other Name: Adipex- P

Study Arms

• 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.
  Intervention: Drug: Phentermine and B12
• 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.
  Intervention: Drug: Phentermine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2012): 22
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01719185
• Other Study ID Numbers: 12-001323
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Michael Lang, East Carolina University
• Original Responsible Party: Same as current
• Current Study Sponsor: Dr. Michael Lang
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: East Carolina University
• Verification Date: August 2015