GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolution
| ISRCTN | ISRCTN10551314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10551314 |
| EudraCT/CTIS number | 2015-005402-11 |
| Secondary identifying numbers | 32498 |
- Submission date
- 21/11/2016
- Registration date
- 28/11/2016
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). One of the most common causes of T2DM is obesity. Although weight loss can help significantly in the treatment of T2DM, the treatments used for diabetics can make it harder for a person to lose weight. Bariatric surgery (weight loss surgery) is a drastic measure used to help people who are dangerously overweight. Laparoscopic adjustable gastric band (LAGB) is a surgical weight-loss (bariatric) procedure increasingly used in the UK. It involves surgically placing a band around the top portion of the stomach to lower the capacity of the stomach, helping the person to lose weight. Although other bariatric surgery procedures produce more predictable weight reduction and diabetes resolution, LAGB is much easier to perform, has a significantly lower death rate and is cheaper. It is therefore important to explore mechanisms to improve LAGB success. Liraglutide is a drug which is similar to a natural gut hormone produced by the body which stimulates post-meal insulin secretion and reduces appetite. The aim of this study is to find out whether a combination of liraglutide and LAGB is likely to offer extremely obese patients with diabetes the opportunity of achieving significant weight loss and diabetes resolution with minimal surgical risk.
Who can participate?
Obese adults with T2DM.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo treatment with liraglutide in addition to their usual treatment six weeks after their gastric band surgery. Those in the second group undergo treatment with a placebo (dummy medicine) in addition to their usual treatment six weeks after their gastric band surgery. In both groups, the medication is injected once a day using a pen-injector. Specific instructions regarding how to use the pen-injector and the drug regime are provided. Patients receive treatment for 6 months and continue to be followed up for another 6 months after treatment has finished. Participants are required to attend six hospital visits and take part in one telephone call during the trial. The visits include the collection of blood samples, completion of questionnaires and other information required for the trial.
What are the possible benefits and risks of participating?
Participants will have frequent contact with members of the research team so any problems can be quickly identified and addressed. Test results and explanations will be provided so patients will have more information about their health, this can help educate and encourage patients to make changes to their lifestyle and diabetes care. Participating in this research may lead to changes in the future that will be beneficial to others undergoing gastric band surgery. From visit two, travel expenses will be available up to a maximum of £10 per visit. There are some risks associated with participating in the study. Blood samples will need to be taken as part of the trial and there is a small chance of fainting, bruising, bleeding, swelling or infection where the needle is inserted. The risk will be minimised by having qualified and experienced staff members perform this procedure. Where possible, research blood samples will be taken at the same time as routine care blood samples so patients will not be exposed to additional needles for the research. There is also a time commitment in participating, however, appointments and tests will be scheduled alongside routine visits if possible. If participants are randomly allocated to take Liraglutide, there are some side effects associated with this medication, which will be explained prior to agreeing to take part.
Where is the study run from?
Guy's and St Thomas' NHS Foundation Trust, Heartlands Hospital, Southmead Hospital (UK)
(updated 10/05/2021, previously:
1. Guy's Hospital (UK)
2. St Thomas’ Hospital (UK)
3. King’s College Hospital (UK)
4. Musgrove Park Hospital (UK))
When is the study starting and how long is it expected to run for?
June 2015 to March 2021 (updated 10/05/2021, previously: June 2020)
Who is funding the study?
Novo Nordisk Limited (UK & Ireland)
Who is the main contact?
Ms Gemma Cutting
gemma.cutting@gstt.nhs.uk
Contact information
Public
Department of Diabetes and Endocrinology
Guys Hospital
3rd Floor Southwark Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
| Phone | +44 20 7188 1929 |
|---|---|
| gemma.cutting@gstt.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Impact of the Combination of the GLP-1 Analogue Liraglutide (Victoza®) and Laparoscopic Adjustable Gastric Banding (LAGB) on Diabetes Control |
| Study acronym | GLIDE |
| Study hypothesis | The aim of this study is to evaluate the impact of liraglutide plus laparoscopic adjustable gastric band (LAGB) on diabetes control. |
| Ethics approval(s) | London – Westminster Research Ethics Committee, 20/07/2016, ref: 16/LO/1144 |
| Condition | Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus |
| Intervention | Following laparoscopic adjustable gastric band (LAGB), patients will be randomised to receive liraglutide or placebo. Randomisation will be carried out by a computer generated randomisation package. Patients will be stratified by duration of diabetes, BMI, centre and use of insulin through minimisation with a random component to ensure balance between treatment arms. Patients will be assigned to either injectable Liraglutide treatment or injectable placebo. Liraglutide (or placebo) will be titrated as recommended to the maximum tolerated dose or 1.8mg. Dose escalation will be based on tolerability of previous dose. Participants will inject liraglutide/placebo daily for 6 months (including titration phase). Participants will then be followed up for a further 6 months after they have stopped taking the intervention. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Liraglutide |
| Primary outcome measure | Difference in glycated haemoglobin (HbA1C) is measured using a glycated haemoglobin blood test at baseline and 6 months. |
| Secondary outcome measures | 1. Difference in glycated Haemoglobin (HbA1c) is measured using a glycated haemoglobin blood test at baseline and 12 months 2. Percentage of patients achieving diabetes remission comprising a HbA1c level of less than 6.5% and off all diabetes medications is measured by HbA1c blood test and clinical review/patient interview at months 3, 6, 9 and 12. 3. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is measured using fasting glucose, insulin and c-peptide blood tests at baseline, 6 and 12 months 4. Number of reported hypoglycaemic episodes are measured by clinical interview at months 3, 6, 9 and 12. 5. Anthropometric measures and body composition (height, weight, waist and neck circumference, BMI and Bioimpedance (Body Fat via Bioelectrical Impedance)) are measured at baseline, 3, 6 and 12 months 3. Physical activity levels are recorded using the General Physical Activity Questionnaire at baseline, 6 and 12 months 4. Cardiovascular disease risk factors (Systolic and Diastolic BP; total cholesterol, HDL-cholesterol, LDL-cholesterol and Triglyceride) are measured using a sphygmomanometer and blood testing at baseline, 3, 6 and 12 months 5. Quality of life is measured using the Impact of Weight on Quality of Life-Lite (IWQoL-Lite) Questionnaire, at baseline, 3, 6 and 12 months 6. Depression, anxiety and emotional distress is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 6 and 12 months. 6. Adverse event rates recorded by clinical interview at baseline, 3, 6 and 12 months |
| Overall study start date | 01/06/2015 |
| Overall study end date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 152; UK Sample Size: 152 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 30/11/2016 |
| Recruitment end date | 31/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE1 9RT
United Kingdom
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
16th Floor Tower Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 20 7188 5732 |
|---|---|
| jennifer.boston@gstt.nhs.uk | |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2018 to 31/03/2020.
2. The overall end date was changed from 30/06/2020 to 31/03/2021.
3. The intention to publish date was changed from 31/12/2020 to 01/03/2022.
4. The plain English summary was updated to reflect these changes.
5. The trial participating centres Guy's Hospital, St Thomas’ Hospital, King’s College Hospital, Musgrove Park Hospital were removed and Guy's and St Thomas' NHS Foundation Trust, Heartlands Hospital, Southmead Hospital were added.
