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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01831648
First received: April 3, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Population
Other: Blood sample

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Open, Prospective, National, Multicenter, Non Randomised, Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Concentration of IGF1 in serum [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Establishment of a bank of frozen sera to further develop these standards [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]

Enrollment: 924
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volonteers
Blood sample
Other: Blood sample

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.     

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831648

Locations
France
Assistance Publique - Hôpitaux de Paris
Le KREMLIN-BICETRE, France, 94 275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe CHANSON, Professor Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01831648     History of Changes
Other Study ID Numbers: P081216
Study First Received: April 3, 2013
Last Updated: April 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
IGF1
standards
Assays
Z-score
Healthy volunteers
Population

ClinicalTrials.gov processed this record on April 22, 2014