Clinical trial NCT01353118: The Effects of Glycemic Optimization Before Gastric Bypass Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
bariatric surgery
Roux-en-y gastric bypass
retinopathy
neuropathy
nephropathy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
timeFrame: 1 year
Secondary outcomes:
measure: A Composite of Microvascular Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Weight Centre, Charing Cross Hospital,
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Carel Le Roux, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: