| Trial ID: | L6345 |
| Source ID: | NCT01257087
|
| Associated Drug: |
Insulin
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| 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
|