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Clinical Trial Details

Trial ID: L3459
Source ID: NCT01493934
Associated Drug: Injection Of 6-Dig
Title: Development of a Fast Measurement Technique of Insulin Resistance in Human
Acronym: GLUCIMAG
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: injection of 6-DIG
Outcome Measures: Primary: Change of glycemia, Assessment of tolerance to insulin resistance measurement technique with 6-DIG scintigraphy, in healthy volunteers * clinical tolerance to 6-DIG infusion * clinical and biological tolerance to insulin infusion * evaluation of dosimetry, Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours) | Secondary: insulinemia, Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)|clinical side effects, hypoglycemia symptoms, Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)|dosimetry, organs biodistribution of radioactivity, during the 24 hours following injection of 6-DIG|insulin resistance, scintigraphic measurement of glucose transport in heart before and after infusion of insulin, 0-15 minutes following 6-DIG infusion
Sponsor/Collaborators: Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Gender: ALL
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2010-04
Completion Date: 2013-03
Results First Posted:
Last Update Posted: 2016-02-24
Locations: Service de Biophysique et Médecine Nucléaire, CHU de Grenoble, Grenoble, France
URL: https://clinicaltrials.gov/show/NCT01493934