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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588093
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Peter Bang, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Increlex Drug: 0.9% Saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Insulin-like Growth Factor (IGF-I) Induced Muscle Glucose Uptake and Interstitial IGF-1 Concentrations.
Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mecasermin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 23 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588093

Pediatric Endocrinology Unit, Dept of Women's and Children's Health, Karolinska Institute & University Hospital
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Peter Bang
Principal Investigator: Peter Bang, Professor Karolinska University Hospital, Pediatric Endicrinology Unit, Dept of Women´s and Children´s Health

Responsible Party: Peter Bang, Professor, Karolinska University Hospital Identifier: NCT01588093     History of Changes
Other Study ID Numbers: MDIGF-1
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Growth Substances
Physiological Effects of Drugs