GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolutio

Not Applicable

Completed

• Conditions: Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN10551314
• Lead Sponsor: IHR Guy's & St Thomas' NHS Foundation Trust (GSTFT)/King’s College London (KCL) Biomedical Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-28
• Study Completion: 2021-03-31
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified