IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01588093|
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Increlex Drug: 0.9% Saline||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Insulin-like Growth Factor (IGF-I) Induced Muscle Glucose Uptake and Interstitial IGF-1 Concentrations.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588093
|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|