Clinical trial NCT01831648: Establishment of Reference Values for Insulin-like Growth Factor 1 (IGF1) in the General Population
Official title: An Open, Prospective, National, Multicenter, Non Randomised, Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Population
Keywords: IGF1
standards
Assays
Z-score
Healthy volunteers
Population
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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)

Primary outcomes:
measure: Concentration of IGF1 in serum
timeFrame: up to 4 hours
Secondary outcomes:
measure: Development of an expression results in Z-score for all assays to overcome the differences related to different immunoassays.
timeFrame: up to 4 hours
measure: Establishment of a bank of frozen sera to further develop these standards
timeFrame: up to 4 hours
Other outcomes:
Locations:
city: Le KREMLIN-BICETRE
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
name: Philippe CHANSON, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabbah N, Wolf P, Piedvache C, Trabado S, Verdelet T, Cornu C, Souberbielle JC, Chanson P. Reference values for IGF-I serum concentration in an adult population: use of the VARIETE cohort for two new immunoassays. Endocr Connect. 2021 Aug 26;10(9):1027-1034. doi: 10.1530/EC-21-0175.
citation: Loeb E, Becquemont L, Corruble E. Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression? : Commentary on Hess et al. 2017. Psychopharmacology (Berl). 2021 Feb;238(2):613-614. doi: 10.1007/s00213-020-05747-x. Epub 2021 Jan 9. No abstract available.
citation: Mariette X, Perrodeau E, Verner C, Struillou X, Picard N, Schaeverbeke T, Constantin A, Ravaud P, Bouchard P. Role of good oral hygiene on clinical evolution of rheumatoid arthritis: a randomized study nested in the ESPOIR cohort. Rheumatology (Oxford). 2020 May 1;59(5):988-996. doi: 10.1093/rheumatology/kez368.
citation: Mavromati M, Kuhn E, Agostini H, Brailly-Tabard S, Massart C, Piketty ML, Arnoux A, Young J, Souberbielle JC, Chanson P. Classification of Patients With GH Disorders May Vary According to the IGF-I Assay. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2844-2852. doi: 10.1210/jc.2017-00202.
citation: Chanson P, Arnoux A, Mavromati M, Brailly-Tabard S, Massart C, Young J, Piketty ML, Souberbielle JC; VARIETE Investigators. Reference Values for IGF-I Serum Concentrations: Comparison of Six Immunoassays. J Clin Endocrinol Metab. 2016 Sep;101(9):3450-8. doi: 10.1210/jc.2016-1257. Epub 2016 May 11.