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

NCT ID: NCT00646815

Last Updated: 2009-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Growth Hormone Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

growth hormone (genotropin)

Intervention Type DRUG

Dosage regulation will follow the local recommendations of GHD treatment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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growth hormone (genotropin)

Dosage regulation will follow the local recommendations of GHD treatment

Intervention Type DRUG

Eligibility Criteria

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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


* 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
* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Jens OL Jorgensen, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Medical Department M, Aarhus University Hospital, Aarhus, Denmark

Locations

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

Aarhus, Aarhus, Denmark

Site Status

Medical Department M, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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Other Identifiers

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LM2008

Identifier Type: -

Identifier Source: org_study_id

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