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临床试验/ISRCTN13643081
ISRCTN13643081已完成未知

The GRAVITAS trial: GLP­1 Receptor Agonist interVentIon for poor responders afTer bariAtric Surgery

Imperial College London0 个研究点目标入组 80 人开始时间: 2016年1月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
80

研究概览

简要总结

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31174993 (added 10/06/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged between 18­ and 70 years
  • 2. 12 months after gastric bypass or sleeve gastrectomy bariatric surgery
  • 3. Diagnosed with Type 2 diabetes mellitus
  • 4. HbA1c greater than 6.5% (more than 48 mmol/mol) on screening
  • 5. On Metformin ± long acting insulin
  • 6. Able to give informed consent

排除标准

  • 1. Diagnosis of Type 1 diabetes mellitus
  • 2. Anatomical or endocrinological pathology causing poor weight loss or weight regain
  • 3. Screening calcitonin of 50 ng/L or above
  • 4. Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
  • 5. Personal history of non­familial medullary thyroid carcinoma
  • 6. History of acute or chronic pancreatitis
  • 7. Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100
  • mmHg or above)
  • 8. Estimated glomerular filtration rate (eGFR) less than30 ml/min per 1.73 m2
  • 9. Current pregnancy
  • 10. Inability to maintain adequate contraception

研究者

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