The Effects of Glycemic Optimization Before Gastric Bypass Surgery
NCT ID: NCT01353118
Last Updated: 2022-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2011-05-31
2016-12-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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gastric bypass
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
No interventions assigned to this group
Gastric bypass 2
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
Optimise glucose control within 3 months before operation
Interventions
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gastric bypass
Optimise glucose control within 3 months before operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Carel Le Roux
Consultant metabolic medicine
Principal Investigators
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Carel Le Roux, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial Weight Centre, Charing Cross Hospital,
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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Other Identifiers
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GLUCOSURG 2
Identifier Type: -
Identifier Source: org_study_id
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