Brody Outpatient of Brody Medical Sciences Module D
Greenville, North Carolina, 27834, United States
NCT Number: NCT01719185
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Greenville, North Carolina, 27834, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Individuals can participate in the study if they meet the following inclusion criteria:
Individuals should not participate in if any of the following apply to them:
Other names: Adipex-P, Cyanocobalamin
Other names: Adipex- P
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.
Time frame: 24 weeks
Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.
Time frame: 24 weeks
Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
Time frame: 24 weeks
Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.
Dr. Michael Lang
Other
A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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