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

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120977
• Other study ID #: 25274
• Status: Completed
• Phase: N/A
• First received: May 7, 2010
• Last updated: November 4, 2011
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Locations

Country	Name	City	State
Denmark	Aarhus university hospital NBG	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark,