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| Sponsors and Collaborators: |
University of Aarhus Aarhus University Hospital Novo Nordisk |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00568568 |
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: somatropin |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Crossover Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 2: No Intervention |
Drug: somatropin
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).
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas K-Hafstrøm, MD | 89492071 ext + 45 | tk-h@ki.au.dk |
| Contact: Jens Otto L Jørgensen, MD, DMSc | joj@ki.au.dk |
| Denmark | |
| Department M (endocrinology and diabets) | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Thomas K-Hafstrøm, MD 89492071 ext + 45 tk-h@ki.au.dk | |
| Contact: Jens Otto L Jørgensen, MD joj@ki.au.dk | |
| Principal Investigator: | Jens Otto L Jørgensen, MD, DMSc | Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark |
More Information
| Responsible Party: | Det Sundhedsvidenskabelige Fakultet ( Aarhus Universitet ) |
| Study ID Numbers: | M-20070176 |
| Study First Received: | December 5, 2007 |
| Last Updated: | January 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00568568 |
| Health Authority: | Denmark: Ethics Committee |
|
Growth Hormone GH signaling Insulin resistance Insulin Signaling |
|
Hyperinsulinism Metabolic Diseases Healthy Insulin Resistance |
Metabolic disorder Glucose Metabolism Disorders Insulin |
|
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
