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

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus university hospital NBG

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 11, 2010
Registry last updated: Nov 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed