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临床试验/NCT01719185
NCT01719185已完成早期 1 期

A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population

Dr. Michael Lang1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Weight Change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Phentermine and B12 (Drug)

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.

干预措施: Phentermine (Drug)

结局指标

主要结局

Weight Change

时间窗: 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.

次要结局

  • Blood Pressure(24 weeks)
  • Waist Circumference(24 weeks)
  • Waist to hip ratio(24 weeks)

研究者

发起方
Dr. Michael Lang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Michael Lang

Michael Lang, MD, Internal Medicine, Psychiatrics

East Carolina University

研究点 (1)

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