Metabolic Studies- Interactions Between GH and Insulin in GHDA
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.
|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|
- Socs 1-3 activity in muscle tissue and degree of insulin resistance [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568568
|Department M (endocrinology and diabets)|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Jens Otto L Jørgensen, MD, DMSc||Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark|