Hypertension, Obesity
Conditions
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.
Interventions
DRUGPhentermine and B12
DRUGPhentermine
Sponsors
Dr. Michael Lang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 24 weeks | Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups. |
| Waist Circumference | 24 weeks | Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups. |
| Waist to hip ratio | 24 weeks | Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group. |
Countries
United States
Outcome results
None listed