Metabolic Studies- Interactions Between GH and Insulin in GHDA

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Drug: Growth hormone

• Registration Number: NCT00568568
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Growth hormone	Growth hormone	-

Primary Outcome Measures

Name	Time	Method
Socs 1-3 activity in muscle tissue and degree of insulin resistance	6 hours

Secondary Outcome Measures

Name	Time	Method
Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue	6 hours

Trial Locations

Locations (1)

Department M (endocrinology and diabets); 🇩🇰 Aarhus, Denmark