IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations
Hormonal disturbances in the GH-IGF-I axis are considered important for the deterioration of glycemic control in T1DM particularly in adolescents. In addition it may have direct implications on the development of insulin resistance and long-term complications.
The Investigators hypothesis is that low circulating IGF-I and compensatory hyper-secretion of GH, in the presence of peripheral insulin excess, results in increased local IGF-I expression explaining both the deterioration in metabolic control and the increased risk for microvascular complications. Correction of imbalance in circulating and tissue-specific levels of IGF-I could lead to both better early metabolic control and to prevention of early diabetic complications in type 1 diabetic (T1DM) patients.
Aim of the present study is to validate the microdialysis technique as a useable tool to predict local biological effects of IGF-1 and to understand the pharmacokinetics of local IGF-I actions after sc injection of Increlex in type 1 diabetic patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Insulin-like Growth Factor (IGF-I) Induced Muscle Glucose Uptake and Interstitial IGF-1 Concentrations.|
- Difference in MD (microdialysate) IGF-1 over time (expressed as AUC or peak microdialysate IGF-I) between saline and IGF-I injection. [ Time Frame: 0-4 hours from injection ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Saline||
Drug: 0.9% Saline
Placebo (0,1 ml of 0.9% Saline) single subcutaneous injection
|Active Comparator: Increlex||
Increlex 120 micrograms/kg body weight single subcutaneous injection
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|Pediatric Endocrinology Unit, Dept of Women's and Children's Health, Karolinska Institute & University Hospital|
|Stockholm, Sweden, SE-17176|
|Principal Investigator:||Peter Bang, Professor||Karolinska University Hospital, Pediatric Endicrinology Unit, Dept of Women´s and Children´s Health|