Establishment of Reference Values for Insulin-like Growth Factor 1 (IGF1) in the General Population (VARIETE)

April 10, 2013 updated by: Assistance Publique - Hôpitaux de Paris

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

Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each assay gives a very different result for the same sample. As IGF-I also varies with age, it is necessary to establish a broad population reference values of IGF1 concentration for each of the IGF1 assays used in clinical practice, taking into account individual variation factors such as age, nutritional status and possible treatments.

The objective of this study is to establish normative data based on a large random selection from the general population, including representation from all age groups (around 100 subjects for each decade age range). This will be performed for all the available assay kits. Subjects with medical conditions and medications that may affect the outcome will be excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and results will be reported as mass units but also as SD scores in order to be able, in a given patient, to compare its IGF-I concentration along time, even if using different assays.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

924

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le KREMLIN-BICETRE, France, 94 275
        • Assistance Publique - Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female 18 to 89 years old (18 years ≤ age ≤ 89 years)
  • Consent given by the patient
  • 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.
  • No medication that can interfere with the concentration of IGF1: steroids, anti-androgens, distal diuretics, anti-estrogens, enzyme inducers (rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, herbal St. John's wort, efavirenz, nevirapine, griseofulvin , OP'DDD, mitotane).
  • No intercurrent illness in the week preceding the inclusion
  • No known chronic infectious disease (BVH, CVH, HIV)
  • No active smoking
  • Weight/height2 (BMI) less than 28 kg/m2 and greater than 19 kg/m2
  • Normal clinical examination
  • Normal blood pressure: children under 65 years (100 mm Hg <SBP <140 mmHg, 50 mmHg <PAD <90 mmHg) for over 65 years (100 mm Hg <SBP <150 mmHg, 50 mmHg <SBP <90mmHg )

Exclusion Criteria:

  • Uncontrolled intercurrent illness
  • Pregnant or lactating woman
  • Excess alcohol consumption: more than 50 g/24h of chronic or acute or unable to restraint from consuming alcohol
  • Susceptible to use drugs
  • Donated blood in the 3 months preceding the study
  • Blood transfusion in the 3 months preceding the test
  • Exclusion period of a previous experimental trial.
  • Fasting extended by several days.
  • Patient not affiliated to a social security system (is or should be beneficiary)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Volonteers
Blood sample
Other: Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of IGF1 in serum
Time Frame: up to 4 hours
Establishment of reference values for the concentration of IGF1 in the general adult population for each of the assays of IGF1 used in clinical practice, taking into account individual variation factors such as age, nutritional status and potential treatments.
up to 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of an expression results in Z-score for all assays to overcome the differences related to different immunoassays.
Time Frame: up to 4 hours
up to 4 hours
Establishment of a bank of frozen sera to further develop these standards
Time Frame: up to 4 hours
up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Philippe CHANSON, Professor, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P081216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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