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

NCT ID: NCT01257087

Last Updated: 2020-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Obesity

Keywords

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Type 2 Diabetes Mellitus Obesity Bariatric Surgery Glycaemic control Microvascular complications Intensive Conservative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Insulin Glargine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Carel Le Roux

Consultant metabolic medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carel W le Roux, MRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GLUCOSURG1

Identifier Type: -

Identifier Source: org_study_id