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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Growth Hormone Deficiency

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Male

No interventions assigned to this group

Female

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens O Jørgnsen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus university hospital NBG

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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25274

Identifier Type: -

Identifier Source: org_study_id