The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
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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 |
- 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.
- 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 |
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| United States, North Carolina | |
| Brody Outpatient of Brody Medical Sciences Module D | |
| Greenville, North Carolina, United States, 27834 | |
| 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 Obesity Weight Loss Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes Phentermine Vitamin B 12 Central Nervous System Stimulants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013