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临床试验/NCT03603080
NCT03603080终止4 期

A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Hartford Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
12
试验地点
1
主要终点
Weight loss percentage

研究概览

简要总结

The study will investigate the effects of Metformin and Topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. The investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. Patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Hartford Hospital's Bariatric and Metabolic Surgery Program will be screened, consented and enrolled in the study. Prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following LSG. For those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-LSG at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. Once randomly assigned to the medication group, patients will receive Metformin or Topiramate based upon physician judgment and medical history. Dosages will not be adjusted during the course of the study. The primary outcome will be % total body weight loss (%TWL) at 6 months following surgery, as the majority of the weight loss after LSG occurs during the first 6 months. Data collected through up to 12 months will be analyzed. The %TWL for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-LSG. Resolution of comorbidities will be noted.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for sleeve gastrectomy as primary bariatric treatment

排除标准

  • Qualified for Roux en Y gastric bypass
  • On FDA approved weight loss medications prior to bariatric surgery
  • Required to continue Topiramate, Zonisamide, and Buproprion for other chronic diseases after bariatric surgery
  • On Metformin, Dulaglutide, Exenatide, Exenatide Extended Release, Liraglutide, Empaglifozin, Canaglifozin, Dapaglifozin, Buproprion, Zonisamide, and Topiramate, prior to surgery.
  • Have had lap band or other prior bariatric surgery
  • Glomular filtration rate < 45
  • Over 70 years old
  • Not fluent in English

研究组 & 干预措施

Medication arm

Experimental

干预措施: Administration of weight loss drug (Metformin or Topiramate) (Drug)

结局指标

主要结局

Weight loss percentage

时间窗: one year

Percent of total body weight lost

次要结局

  • Rate of Sleep apnea resolution(One year)
  • Rate of High cholesterol resolution(One year)
  • Rate of GERD resolution(One year)
  • Rate of Diabetes Resolution(One year)
  • Rate of High blood pressure resolution(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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