Metabolic Studies- Interactions Between GH and Insulin in GHDA

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00568568

Collaborator

Aarhus University Hospital (Other), Novo Nordisk A/S (Industry)

Enrollment

Location

Arm

26.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Dec 1, 2007

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

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 Names: Norditropin, Novo Nordisk

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 Names:

Norditropin, Novo Nordisk

Outcome Measures

Primary Outcome Measures

Socs 1-3 activity in muscle tissue and degree of insulin resistance [6 hours]

Secondary Outcome Measures

Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department M (endocrinology and diabets)	Aarhus		Denmark	8000

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital
Novo Nordisk A/S

Investigators

Principal Investigator: Jens Otto L Jørgensen, MD, DMSc, Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark