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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Bang, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01588093
First received: April 7, 2012
Last updated: April 27, 2012
Last verified: April 2012
  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.

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Type 1 diabetes duration at least two years and assumed C-peptide negativity
  2. Chronological age from 18 to 25 years
  3. Tanner stage > 4 (Girls: Tanner B4 or more, Boys: Testis > 15 ml)
  4. Levemir or Lantus as basal analogue or CSII
  5. IGF-1 < -1.0 SDS and HbA1C < 73 mmol/mol with screening or within past three months
  6. Written informed consent

Exclusion Criteria:

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588093

Locations
Sweden
Pediatric Endocrinology Unit, Dept of Women's and Children's Health, Karolinska Institute & University Hospital
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Peter Bang
Investigators
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014