Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

This study has been completed.

Sponsor:

Collaborator:

Aarhus University Hospital

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT00646815

First received: February 19, 2008

Last updated: October 21, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2008

Last Updated Date

October 21, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

insulin sensitivity [ Time Frame: before and after 3 months treatment with growth hormone ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00646815 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

substrate metabolism [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]
intrahepatic lipid content [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]
intramyocellular lipid content [ Time Frame: before and after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Official Title ^ICMJE

Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Brief Summary

The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Growth Hormone Deficiency

Intervention ^ICMJE

Drug: growth hormone (genotropin)

Dosage regulation will follow the local recommendations of GHD treatment

Study Arm (s)

Experimental: a
the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency

Intervention: Drug: growth hormone (genotropin)
No Intervention: Control
Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent
Must be of legal age and competent
Age: >18 and <60 years old
Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study

Exclusion Criteria:

Alcohol consumption >21 units per week
Malignant disease
Pregnancy
Magnetic implants or material in the body
Claustrophobia
BMI >30
Heart disease (NYHA >2)
Uncontrolled hypertension
Manifest diabetes mellitus
Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Controls are matched on age, gender and BMI

Inclusion Criteria:

Written informed consent
Must be of legal age and competent

Exclusion Criteria:

Alcohol consumption >21 units per week
Malignant disease
Pregnancy
Magnetic implants or material in the body
Claustrophobia
Heart disease (NYHA >2)
Uncontrolled hypertension
Manifest diabetes mellitus
Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00646815

Other Study ID Numbers ^ICMJE

LM2008

Has Data Monitoring Committee

Responsible Party

Louise Møller, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Aarhus University Hospital

Investigators ^ICMJE

Principal Investigator:

Jens OL Jorgensen, Professor MD

Medical Department M, Aarhus University Hospital, Aarhus, Denmark

Information Provided By

University of Aarhus

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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