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

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ClinicalTrials.gov Identifier: NCT01257087
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Drug: Insulin Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.
Study Start Date : December 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensive glycaemic control
Intensive glycaemic control 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.
 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
Conservative glycaemic control 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Patients will be tested off all antidiabetes medications if safe to do so


Secondary Outcome Measures :
  1. 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 ]
  2. Microvascular events [ Time Frame: 1 year after surgery ]
    Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Carel Le Roux, Consultant metabolic medicine, Imperial College London
ClinicalTrials.gov Identifier: NCT01257087     History of Changes
Other Study ID Numbers: GLUCOSURG1
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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