The Effects of Glycemic Optimization Before Gastric Bypass Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01353118
Study type	Interventional
Source	Imperial College London
Contact
Status	Completed
Phase	N/A
Start date	May 2011
Completion date	December 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effects of Glycemic Optimization Before Gastric Bypass Surgery — GLUCOSURG2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms