Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery - Full Text View

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	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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Insulin Insulin human Insulin glargine

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 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 (Adult)
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

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: 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


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:	April 30, 2015
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 Insulin, Globin Zinc Insulin Insulin Glargine Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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