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Metabolic Studies- Interactions Between GH and Insulin in GHDA

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Growth hormone
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Growth Hormone, GH signaling, Insulin resistance, Insulin Signaling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department M (endocrinology and diabets)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Growth hormone

Arm Description

Outcomes

Primary Outcome Measures

Socs 1-3 activity in muscle tissue and degree of insulin resistance

Secondary Outcome Measures

Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue

Full Information

First Posted
December 5, 2007
Last Updated
January 18, 2013
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00568568
Brief Title
Metabolic Studies- Interactions Between GH and Insulin in GHDA
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Growth Hormone, GH signaling, Insulin resistance, Insulin Signaling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Growth hormone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Norditropin, Novo Nordisk
Intervention Description
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).
Primary Outcome Measure Information:
Title
Socs 1-3 activity in muscle tissue and degree of insulin resistance
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
Time Frame
6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, MD, DMSc
Organizational Affiliation
Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department M (endocrinology and diabets)
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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