GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolutio
- Conditions
- This trial will investigate the effects of the study treatment arms (gastric band + placebogastric band + liraglutide) on diabetes resolution in obese patients.MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2011-001538-41-GB
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;<br> Primary end point(s): The primary outcome is the percentage of patients with diabetes resolution as defined by fasting blood glucose levels of <7mmol/L.<br> ;<br> Main Objective: The study will seek to address the following major questions regarding liraglutide combined with the gastric band:<br><br> When compared with band alone, will the combination treatment result in greater -<br><br> 1. diabetes resolution<br> 2. weight loss and reduction in body fat<br> 3. change in quality of life<br> 4. reduction in cardiovascular risk<br><br><br>
- Secondary Outcome Measures
Name Time Method