Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 150
- Locations
- 1
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.