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Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01120977
First received: May 7, 2010
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.


Condition
Growth Hormone Deficiency

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Biospecimen Retention:   Samples With DNA

Blood sample to measure "Insulin like growth factor-1" (IGF-1)


Enrollment: 150
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Male
Female

Detailed Description:

The treatment of Growth Hormone deficiency (GHD) patients with GH, has since 1994 been approved in several countries. The approval is based on studies that show positive effect on body composition, physiology, lipid profile, bone density and life quality. One often observed side effect is fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness.

By comparing the body bioelectric impedance (BIA) with an Arm Muscle Area (AMA) measurement, it is possible to determine the hydrations status of a person. This measurement is a simple and non invasive method to evaluate the GH dosages applied in the treatment of GHD persons.

The objective of this study is to create BIA/AMA reference data of healthy persons of both genders in the age 20-70 years.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The subjects are healthy persons in the age 20-70 years, both males and females will be recruited from the city Aarhus in Denmark.

Criteria

Inclusion Criteria:

  • Healthy persons,
  • Age 20- 70 years.

Exclusion Criteria:

  • Cardiac implanter (pacemaker),
  • Heart insufficiency, chronic venuos insufficiency,
  • Use of diuretics, desmopressin, neuroleptica, antidepressants, corticosteroids, fludrocotidon,
  • Obesity (BMI > 30),
  • Knowledge of changes in electrolyte or water homeostasis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120977

Locations
Denmark
Aarhus university hospital NBG
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens O Jørgnsen, Professor University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01120977     History of Changes
Other Study ID Numbers: 25274
Study First Received: May 7, 2010
Last Updated: November 4, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
 Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013