The Effects of Glycemic Optimization Before Gastric Bypass Surgery

Type 2 Diabetes Clinical Trial

— GLUCOSURG2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353118
• Other study ID #: GLUCOSURG 2
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Biological:
• gastric bypass
Optimise glucose control within 3 months before operation

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London
United Kingdom	Imperial Weight Centre, Charing Cross Hospital,	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.	A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission.; The outcome measure is calculated as the count of participants achiving the above criteria	1 year
Secondary	A Composite of Microvascular Complications	A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.; The outcome measure is calculated as the count of participants developing any of the microvascular events.	1 year