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

Primary Purpose

Growth Hormone Deficiency

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

About this trial

This is an interventional basic science trial for Growth Hormone Deficiency focused on measuring insulin sensitivity, substrate metabolism, fatty liver, intramyocellular lipids, growth hormone deficiency, Growth hormone deficiency (Adult)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

a

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

insulin sensitivity

Secondary Outcome Measures

substrate metabolism
intrahepatic lipid content
intramyocellular lipid content

Full Information

First Posted
February 19, 2008
Last Updated
October 21, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00646815
Brief Title
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Official Title
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
Keywords
insulin sensitivity, substrate metabolism, fatty liver, intramyocellular lipids, growth hormone deficiency, Growth hormone deficiency (Adult)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
growth hormone (genotropin)
Intervention Description
Dosage regulation will follow the local recommendations of GHD treatment
Primary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
before and after 3 months treatment with growth hormone
Secondary Outcome Measure Information:
Title
substrate metabolism
Time Frame
before and after 3 months of growth hormone treatment
Title
intrahepatic lipid content
Time Frame
before and after 3 months of growth hormone treatment
Title
intramyocellular lipid content
Time Frame
before and after 3 months of growth hormone treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens OL Jorgensen, Professor MD
Organizational Affiliation
Medical Department M, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Medical Department M, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://person.au.dk/da/joj@afdm.au.dk/act
Description
Jens Otto Lunde Jorgensen
URL
http://person.au.dk/da/louisem@dadlnet.dk/
Description
Louise Møller
URL
http://www.datatilsynet.dk/english/
Description
Danish Data Protection Agency

Learn more about this trial

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

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