ISRCTN10551314已完成未知
The Impact of the Combination of the GLP-1 Analogue Liraglutide (Victoza®) and Laparoscopic Adjustable Gastric Banding (LAGB) on Diabetes Control
IHR Guy's & St Thomas' NHS Foundation Trust (GSTFT)/King’s College London (KCL) Biomedical Research Centre0 个研究点目标入组 152 人开始时间: 2016年11月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients with type 2 diabetes
- •2. HbA1c =6.5% and <11% at screening
- •3. Age 18-70 years
- •4. Patients with a BMI equal to or above 30kg/m2 (or 27kg/m2 and of Asian family origin) at screening
- •5. Patients undergoing LAGB based on NICE criteria and multidisciplinary assessment
- •6. Written informed consent to participate
排除标准
- •1. Patients with type 1 diabetes (based on clinical history)
- •2. Patients who refuse or are unable to have injectable treatment post operatively
- •3. Patients with any disability preventing use of treatment
- •4. Patients with known delayed gastric emptying (diagnosed by clinical history and judgment)
- •5. Any contraindication to liraglutide use (inflammatory bowel disease, ketosis, diabetic gastroparesis (based on clinical assessment), DPP-4 inhibitors, pregnancy and breast-feeding, renal impairment (eGFR < 30mL/min/1.73m2) and hepatic impairment; acute pancreatitis (persistent, severe abdominal pain))
- •6. Type 2 diabetes controlled purely through diet
- •7. Pregnancy or breastfeeding or planning to become pregnant during the study period and women of childbearing age who are not using adequate contraceptive methods (defined as: established use of oral, injected or implanted hormonal methods of contraception; placement of intrauterine device or intrauterine system; barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository); female sterilisation; male sterilisation (where partner is the sole partner of subject); true abstinence (when in line with preferred and usual lifestyle)
- •8. Personal or family history of thyroid cancer or multiple endocrine neoplasia
- •9. History of previous pancreatitis
- •10. Administration of a GLP-1 agonist or DPP-IV inhibitor after a time-point one week prior to surgery
- •11. Patients who display insufficient understanding of the trial procedures following reasonable attempts by the investigator to provide information, at the discretion of the investigator
研究者
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