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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01120977
Other study ID # 25274
Secondary ID
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


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, 

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