Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment gastric bypass
Sponsor Imperial College London
Start date May 2011
End date October 2018
Trial size 150 participants
Trial identifier NCT01353118, GLUCOSURG 2

Summary

Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether:

- metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission.

- metabolic surgery is safe for microvascular complications of Type 2 diabetes

- good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes.

This study aims to assess:

1. whether metabolic surgery is better for diabetes control compared to medical treatment.

2. whether metabolic surgery is safe for eye, nerve and kidney complications.

3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
(Active Comparator)
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia
gastric bypass Type 2 diabetes
Optimise glucose control within 3 months before operation
(No Intervention)
Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.

Primary Outcomes

Measure
Composite of fasting glucose, glycosylated haemoglobin c and rates of Type 2 Diabetes mellitus remission.
time frame: 1 year

Secondary Outcomes

Measure
A composite of microvascular complications
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. Adult patients with T2DM and BMI above 35kg/m2 2. HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication. Exclusion Criteria: - End stage retinopathy, nephropathy or neuropathy.

Additional Information

Official title Investigation of the Effects of Glycaemic Optimisation Before Gastric Bypass Surgery on the Glycaemic Remission and Microvascular Complication Rates of Type 2 Diabetes Mellitus
Principal investigator Carel Le Roux, MBChB, PhD
Description This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group). Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control. Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia. Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Imperial College London.