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

NCT01588093 | Completed DMC

• 1 other identifier: MDIGF-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Difference in MD (microdialysate) IGF-1 over time (expressed as AUC or peak microdialysate IGF-I) between saline and IGF-I injection.

  0-4 hours from injection

Study Arms (2)

Saline

PLACEBO COMPARATOR

Drug: 0.9% Saline

Increlex

ACTIVE COMPARATOR

Drug: Increlex

Interventions

Increlex DRUG

Increlex 120 micrograms/kg body weight single subcutaneous injection

Increlex

0.9% Saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peter Bang: lead

Study Sites (1)

Pediatric Endocrinology Unit, Dept of Women's and Children's Health, Karolinska Institute & University Hospital

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

mecasermin; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peter Bang, Professor

  Karolinska University Hospital, Pediatric Endicrinology Unit, Dept of Women´s and Children´s Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

SE (1)