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

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Brief Title

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

Official Title

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

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 Type

Observational




Condition

Growth Hormone Deficiency


Study Arms / Comparison Groups

 Male
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

May 2010

Completion Date

August 2011

Primary Completion Date

July 2011

Eligibility Criteria

        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.
      

Gender

All

Ages

20 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jens O Jørgnsen, Professor, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT01120977

Organization ID

25274


Responsible Party

Sponsor

Study Sponsor

University of Aarhus


Study Sponsor

Jens O Jørgnsen, Professor, Principal Investigator, University of Aarhus


Verification Date

November 2011