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

October 21, 2009 updated by: University of Aarhus
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
      • Aarhus, Denmark, 8000
        • Medical Department M, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: growth hormone (genotropin)
Dosage regulation will follow the local recommendations of GHD treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity
Time Frame: before and after 3 months treatment with growth hormone
before and after 3 months treatment with growth hormone

Secondary Outcome Measures

Outcome Measure
Time Frame
substrate metabolism
Time Frame: before and after 3 months of growth hormone treatment
before and after 3 months of growth hormone treatment
intrahepatic lipid content
Time Frame: before and after 3 months of growth hormone treatment
before and after 3 months of growth hormone treatment
intramyocellular lipid content
Time Frame: before and after 3 months of growth hormone treatment
before and after 3 months of growth hormone treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Jens OL Jorgensen, Professor MD, Medical Department M, Aarhus University Hospital, Aarhus, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2009

Last Update Submitted That Met QC Criteria

October 21, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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