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Clinical Trial Details

Trial ID: L6268
Source ID: NCT01919788
Associated Drug: Insulin (Insuman Rapid)
Title: Intracellular Counter-regulatory Mechanisms Following Low Blood Glucose
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type I|Hypoglycemia
Interventions: DRUG: Insulin (Insuman Rapid)|DRUG: Glucose|OTHER: Saline
Outcome Measures: Primary: Insulin and growth hormone signalling, expressed as CHANGE in phosphorylation of intracellular target proteins and mRNA expression of target genes in muscle- and fat-tissue., Change in phosphorylation of target proteins and mRNA expression of target genes assessed with western blotting technique., Biopsies obtained on each study day (arm). Muscle biopsies: time (t)= -30min, t= 30min and t= 75min. Fat biopsies: t= 30min and t= 75min | Secondary: Intracellular markers of lipid metabolism in muscle- and fat tissue biopsies., Assessed by Western blotting., Biopsies obtained on each study day (arm). Muscle biopsies: time (t)= -30min, t= 30min and t= 75min. Fat biopsies: t= 30min and t= 75min|Metabolism., Assessment of glucose metabolism by forearm pletysmography and heated hand technique (duration of pletysmography = 30 min.), measured twice on each study day (arm) at t= -30-0 min. and t= 50-80 min.|Ghrelin, Measured at t = -30min., t=0min, t=15min, t= 30min., t=45min., t=60min., t= 75min., t=90min. and t=105min. on each study day (arm)|Metabolism, A palmitic acid tracer will be given once per trial day to estimate fatty acid metabolism. Duration 1 hour., once per study day (arm): t 45min - 105min.
Sponsor/Collaborators: Sponsor: University of Aarhus
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-08
Completion Date: 2014-04
Results First Posted:
Last Update Posted: 2019-09-27
Locations: Institute of Clinical Medicine, Aarhus, Aarhus C, 8000, Denmark
URL: https://clinicaltrials.gov/show/NCT01919788