- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257087
Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery (GLUCOSURG1)
October 22, 2020 updated by: Carel Le Roux, Imperial College London
Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, W6 8RF
- Imperial College Healthcare NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 anti-diabetes medications if safe to do so to assess the 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%
|
1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
A list of patients medication will be collected to assess the percentage of Type 2 Diabetes Mellitus patients with a reduction in the doses/number of diabetes medications used preoperatively
|
1 year after surgery
|
Number of Participants With Microvascular Events
Time Frame: 1 year after surgery
|
Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.
|
1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carel W le Roux, MRCP, PhD, Imperial College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 8, 2010
First Posted (Estimate)
December 9, 2010
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLUCOSURG1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Insulin
-
Munich Municipal HospitalNovo Nordisk A/SUnknownType 2 Diabetes MellitusGermany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Poland, Puerto Rico, Russian Federation, United Kingdom, Denmark, France, Israel, Australia, Romania
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, India, Russian Federation, Belgium, Spain, Israel, Croatia, Serbia, North Macedonia, South Africa, Slovenia, Brazil, Poland, Canada, Czechia
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Croatia, Italy, Slovakia, Denmark, Macedonia, The Former Yugoslav Republic of, Norway, Russian Federation, Finland, France, Poland, Greece, Romania, Sweden, Czech Republic, Argentina
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, France, Austria, Norway, Algeria
-
Novo Nordisk A/STerminatedDiabetes | Diabetes Mellitus, Type 1United Kingdom
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany, United Kingdom