Metabolic Studies- Interactions Between GH and Insulin in GHDA

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: NCT00568568
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : January 21, 2013
Aarhus University Hospital
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Insulin Resistance Drug: Growth hormone Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Socs 1-3 activity in muscle tissue and degree of insulin resistance [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [ Time Frame: 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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): NCT00568568

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

Responsible Party: University of Aarhus Identifier: NCT00568568     History of Changes
Other Study ID Numbers: M-20070176
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

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

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