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The Effects of Glycemic Optimization Before Gastric Bypass Surgery (GLUCOSURG2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London
ClinicalTrials.gov Identifier:
NCT01353118
First received: May 11, 2011
Last updated: January 1, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention
Type 2 Diabetes
Biological: Glycaemic optimisation before surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Composite of fasting glucose, glycosylated haemoglobin c and rates of Type 2 Diabetes mellitus remission. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fasting glucose and HbA1c 1 year after intervention / metabolic surgery. Remission of diabetes will be based on the American Diabetes Association definition.


Secondary Outcome Measures:
  • A composite of microvascular complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.


Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Gastric bypass without pre op glycaemic optimisation
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 with pre op glycaemic optimisation
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
Biological: Glycaemic optimisation before surgery
Optimise glucose control within 3 months before operation
Other Names:
  • gastric bypass
  • Type 2 diabetes
  • glucose optimisation
  • microvascular complications
  • retinopathy
  • neuropathy
  • nephropathy
No Intervention: Best medical care for Type 2 Diabetes Mellitus
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353118

Locations
United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Imperial Weight Centre, Charing Cross Hospital,
London, United Kingdom, W6 8FR
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Carel Le Roux, MBChB, PhD Imperial College London
  More Information

No publications provided

Responsible Party: Carel Le Roux, Consultant metabolic medicine, Imperial College London
ClinicalTrials.gov Identifier: NCT01353118     History of Changes
Other Study ID Numbers: GLUCOSURG 2
Study First Received: May 11, 2011
Last Updated: January 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
diabetes
bariatric surgery
Roux-en-y gastric bypass
retinopathy
neuropathy
nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014