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

NCT01719185 | Completed Early Phase 1 DMC

• 1 other identifier: 12-001323
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood Pressure

  24 weeks

• Waist Circumference

  24 weeks

• Waist to hip ratio

  24 weeks

Study Arms (2)

Phentermine and B12

EXPERIMENTAL

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

Phentermine

ACTIVE COMPARATOR

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

Interventions

Phentermine and B12 DRUG

Also known as: Adipex-P, Cyanocobalamin

Phentermine and B12

Phentermine DRUG

Also known as: Adipex- P

Phentermine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Dr. Michael Lang: lead

Study Sites (1)

Brody Outpatient of Brody Medical Sciences Module D

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

Phentermine; Vitamin B 12

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Michael C Lang, MD

  ECU Physicians General Internal Medicine, Psychiatry

  PRINCIPAL INVESTIGATOR

• James Powell, MD

  ECU Physicians General Internal Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Michael Lang, MD, Internal Medicine, Psychiatrics

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

US (1)