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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by East Carolina University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Michael Lang, East Carolina University
ClinicalTrials.gov Identifier:
NCT01719185
First received: October 30, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity
Hypertension
Drug: Phentermine and B12
Drug: Phentermine
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Weight Change [ Time Frame: 24 weeks (6 months) ] [ Designated as safety issue: No ]
    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:
  • Blood Pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.


Enrollment: 22
Study Start Date: September 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Adipex- P

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719185

Locations
United States, North Carolina
Brody Outpatient of Brody Medical Sciences Module D
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Michael Lang, Michael Lang, MD, Internal Medicine, Psychiatrics, East Carolina University
ClinicalTrials.gov Identifier: NCT01719185     History of Changes
Other Study ID Numbers: 12-001323
Study First Received: October 30, 2012
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Hypertension
Weight Loss
Body Weight
Body Weight Changes
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases
Phentermine
Adrenergic Agents
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014