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

Completed

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT01120977
• Lead Sponsor: University of Aarhus

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Aarhus university hospital NBG; 🇩🇰 Aarhus, Denmark