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Clinical Trial Details

Trial ID: L6345
Source ID: NCT01257087
Associated Drug: Insulin
Title: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery
Acronym: GLUCOSURG1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01257087/results
Conditions: Type 2 Diabetes Mellitus|Obesity
Interventions: DRUG: Insulin
Outcome Measures: Primary: 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%, 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: Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively, 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, Composite of microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy., 1 year after surgery
Sponsor/Collaborators: Sponsor: Imperial College London
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 35
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-12
Completion Date: 2016-08
Results First Posted: 2020-10-22
Last Update Posted: 2020-11-13
Locations: Imperial College Healthcare NHS Trust, London, W6 8RF, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01257087