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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Obesity | Drug: Insulin | Not Applicable |
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 |

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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United Kingdom | |
Imperial College Healthcare NHS Trust | |
London, United Kingdom, W6 8RF |
Principal Investigator: | Carel W le Roux, MRCP, PhD | Imperial College London |
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 |