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

Population Clinical Trial

— VARIETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831648
• Other study ID #: P081216
• Status: Completed
• Phase: N/A
• First received: April 3, 2013
• Last updated: April 10, 2013
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Population

Intervention

Other:
• Blood sample

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Le KREMLIN-BICETRE

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of IGF1 in serum	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	No
Secondary	Development of an expression results in Z-score for all assays to overcome the differences related to different immunoassays.		up to 4 hours	No
Secondary	Establishment of a bank of frozen sera to further develop these standards		up to 4 hours	No