NCT01120977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

May 7, 2010

Last Update Submit

November 4, 2011

Conditions

Study Arms (2)

Male

Female

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects are healthy persons in the age 20-70 years, both males and females will be recruited from the city Aarhus in Denmark.

You may qualify if:

  • Healthy persons,
  • Age 20- 70 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus university hospital NBG

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample to measure "Insulin like growth factor-1" (IGF-1)

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Jens O Jørgnsen, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 11, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations