Insulin-like Growth Factor (IGF-I) induced muscle glucose uptake and interstitial IGF-1 concentrations. Placebo controlled, crossover study of the effect of sc rhIGF-I(Increlex) administration on glucose infusion rate (whole body glucose utilization) and interstitial muscle IGF-1 concentrations under euglycemic clamp conditions in T1DM adolescents and young adults - IGF-I induced muscle glucose uptake and interstitial IGF-I concentrations

• Conditions: Type 1 Diabetes Mellitus; MedDRA version: 12.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependent

• Registration Number: EUCTR2011-000233-37-SE
• Lead Sponsor: Stockholm Läns Landsting, Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Type 1 diabetes duration at least two years and assumed C-peptide negativity
2. Chronological age from 16 to 25 years
3. Tanner stage > 4 (Girls: Tanner B4 or more, Boys: Testis > 15 ml)
4. Levemir or Lantus or Insulatard as basal analogue or CSII
5. IGF-1 < -1.0 SDS and HbA1C < 73 mmol/l with screening or within past three months
6. Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Development of hypoglycemia that can not be controlled with increased glucose infusion-rate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified