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Metabolic Studies- Interactions Between GH and Insulin in GHDA

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Novo Nordisk
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00568568
First received: December 5, 2007
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose og this study is to investigate the effects of growth hormon on insulin signalling pathways and the temporal association between administration of GH and developing of insulin resistance.


Condition Intervention
Insulin Resistance
 Drug: Growth hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolic Studies- Interactions Between GH and Insulin in GHDA. Insulin Resistance and GH Treatment: Dependence of Ambient GH Level Among Patients Treated With GH and Healthy Control Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Socs 1-3 activity in muscle tissue and degree of insulin resistance [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth hormone Drug: Growth hormone
GH infusion from 8.00 pm to 03.00 am (dose 10,2 ng/kg/min) c) GH infusion from 02.00 am to 09.00 am (dose 10,2 ng/kg/min).
Other Name: Norditropin, Novo Nordisk

Detailed Description:

Insulin resistance is a pathophysiological component of type 2 diabetes, obesity and elevated blood pressure. Overall they are syndromes with multifactorial ethology and partly unclarified pathophysiology. Insulin resistance also occur in more seldom diseases with a more unified pathogenesis. Growth hormone deficiency (GHD) in adults with hypopituitarism is an example of one of those seldom diseases. Prolonged GHD is associated with abdominal overweight, dyslipidemia and increased cardiovascular morbidity. Besides, GHD-patients have decreased insulin sensitivity presumably secondary to the altered body composition. Long term effects of GH-substitution improves insulin sensitivity but it is well-known that subcutaneous administration of GH acute worsen insulin sensitivity in both muscles- and liver-tissue. Recently it has been reported that insulin resistance in patients with type 2 diabetes is associated with the induction of a signal protein called suppressor of cytokine signalling (SOCS). It´s interesting that GH also induces a stimulation of SOCS.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written consent before study start
  • Growth Hormone substitution in stable dosis for at least 3 months prior to study start
  • Other substitution in stable dosis for at least 3 months prior to study start

Exclusion Criteria:

  • Medical treatment for diabetes
  • Hypertension even with medical treatment
  • BMI > 30
  • Excessive alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568568

Locations
Denmark
Department M (endocrinology and diabets)
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Novo Nordisk
Investigators
Principal Investigator: Jens Otto L Jørgensen, MD, DMSc Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00568568     History of Changes
Other Study ID Numbers: M-20070176
Study First Received: December 5, 2007
Last Updated: January 18, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Growth Hormone
GH signaling
Insulin resistance
Insulin Signaling

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
 Insulin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 23, 2013