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Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery (GLUCOSURG1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London
ClinicalTrials.gov Identifier:
NCT01257087
First received: December 8, 2010
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.


Condition Intervention
Type 2 Diabetes Mellitus
Obesity
Bariatric Surgery
 Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Percentage of patients with Type 2 Diabetes Mellitus who achieve fasting blood glucose of less than 5.6 mmol/l and/or HbA1c of less than 6% [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Patients will be tested off all antidiabetes medications if safe to do so


Secondary Outcome Measures:
  • Percentage of Type 2 Diabetes Mellitus patients with a reduction in the doses/number of diabetes medications used preoperatively [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
  • Microvascular events [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
    Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive glycaemic control Drug: Insulin
All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Other Name: Insulin Glargine
Active Comparator: Conservative glycaemic control Drug: Insulin
All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Other Name: Insulin Glargine

Detailed Description:

Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257087

Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Carel W le Roux, MRCP, PhD Imperial College London
  More Information

No publications provided

Responsible Party: Carel Le Roux, Consultant metabolic medicine, Imperial College London
ClinicalTrials.gov Identifier: NCT01257087     History of Changes
Other Study ID Numbers: GLUCOSURG1
Study First Received: December 8, 2010
Last Updated: January 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Type 2 Diabetes Mellitus
Obesity
Bariatric Surgery
Glycaemic control
 Microvascular complications
Intensive
Conservative

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013