Completed

VARIETEAn Open, Prospective, National, Multicenter, Non Randomised, Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population

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What is being tested

Blood sample

Other
Who is being recruted

From 18 to 89 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

Healthy subjects will be recruited in 30 centers all around France. A total of 1000 healthy subjects are necessary. Each subject will have a clinical examination with measurement of height and weight. Personal medical history will be recorded and gonadal status evaluated. Biological standard workup will be performed and 80 ml of blood will be sampled and serum will be aliquoted, frozen and stored at -80°C. IGF-I level will be measured with all the assay methods available (sera kept in bank will be used in the future when new methods will be available) For each assay method and each age group (Four 3-years groups between 18 and 30 years and six decade age groups between 30 and 89 years) IGF-I will be measured. Results will be expressed as mean, median, standard deviation, 2.5th and 97.5th percentiles, in mass units. Modelisation according to age and other factors will be performed in order to allow the reporting of IGF-I results for a given individual expression of IGF-I as Z-score.

NCT01831648
Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

924 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate
Consent given by the patient
Male or female 18 to 89 years old (18 years <= age <= 89 years)
No active smoking
No history of : thyroid disease, liver disease or kidney disease or metabolic endocrine disease cardiovascular or pulmonary disease, neoplastic disease, gastroenterological disease (malabsorption, parasites, chronic diarrhea, peptic disease), psychiatric illness, epilepsy
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9 exclusion criteria prevent from participating
Blood transfusion in the 3 months preceding the test
Donated blood in the 3 months preceding the study
Excess alcohol consumption: more than 50 g/24h of chronic or acute or unable to restraint from consuming alcohol
Exclusion period of a previous experimental trial
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Blood sample

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Assistance Publique - Hôpitaux de Paris

Le Kremlin-Bicêtre, FranceOpen Assistance Publique - Hôpitaux de Paris in Google Maps
CompletedOne Study Center