IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations
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Purpose
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 | Intervention |
|---|---|
|
Type 1 Diabetes Mellitus |
Drug: Increlex Drug: 0.9% Saline |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 8 |
| Study Start Date: | April 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Saline |
Drug: 0.9% Saline
Placebo (0,1 ml of 0.9% Saline) single subcutaneous injection
|
| Active Comparator: Increlex |
Drug: Increlex
Increlex 120 micrograms/kg body weight single subcutaneous injection
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 1 diabetes duration at least two years and assumed C-peptide negativity
- Chronological age from 18 to 25 years
- Tanner stage > 4 (Girls: Tanner B4 or more, Boys: Testis > 15 ml)
- Levemir or Lantus as basal analogue or CSII
- IGF-1 < -1.0 SDS and HbA1C < 73 mmol/mol with screening or within past three months
- Written informed consent
Exclusion Criteria:
1. Development of hypoglycemia that can not be controlled with increased glucose infusion-rate
Contacts and Locations| Sweden | |
| 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 |
More Information
No publications provided
| Responsible Party: | Peter Bang, Professor, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01588093 History of Changes |
| Other Study ID Numbers: | MDIGF-1 |
| Study First Received: | April 7, 2012 |
| Last Updated: | April 27, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013