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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Population

Treatments

Other: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT01831648

P081216

Details and patient eligibility

About

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.

Full 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.

Enrollment

924 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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)