IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations

NCT01588093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Increlex

Increlex 120 micrograms/kg body weight single subcutaneous injection

DRUG

0.9% Saline

Placebo (0,1 ml of 0.9% Saline) single subcutaneous injection

Sponsors & Collaborators

  • Peter Bang

    lead OTHER

Principal Investigators

  • Peter Bang, Professor · Karolinska University Hospital, Pediatric Endicrinology Unit, Dept of Women´s and Children´s Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588093 on ClinicalTrials.gov