EUCTR2011-001538-41-GB进行中（未招募）1 期
The impact of the combination of the GLP-1 analogue liraglutide (Victoza) and laparoscopic adjustable gastric banding (LAGB) on diabetes control - GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolution
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult patients with type 2 diabetes and a BMI equal or above 35 kg/m2 who are undergoing laparoscopic adjustable gastric band (LAGB) surgery at our centre based on NICE criteria and multidisciplinary assessment will be included.Type 2 diabates patients undergoing a diet and exercise programme and taking metformin and any sulfonylurea medication. A full medical history (including medications) and medical examination will be carried out at enrolement.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients who refuse or are unable to have injectable treatment post operatively
- •2. Patients with disability preventing use of treatment
- •3. Patients who cannot give consent
- •4. Patients with known delayed gastric emptying
- •5. Patients taking any medications that may interact with the trial medication
- •6. Any contraindications stated in the BNF to liraglutide use (inflammatory bowel disease, ketosis, diabetic gastroparesis (based on clinical assessment), DPP-4 inhibitors, pregnancy and breast feeding, renal impairment (eGFR<60ML/MIN/1.73m2) and hepatic impairment, discontinue treatment if symptoms of acute pancreatitis (persistent, severe abdominal pain)).
- •7. Previous treatment with GLP-1
- •8. Purely diet controlled
- •9. Patients with HbA1C>11%
- •10.Pregnancy or breastfeeding or planning to become pregnant during the study period and women of childbearing age who are not using adequate contraceptive methods
- •11.personal or family history of theyroid cancer or multiple endocrine neoplasia
- •12.History of previous pancreatitis
研究者
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