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

NCT01831648 | Completed DMC

• 1 other identifier: P081216
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

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.

Conditions

Population

Keywords

IGF1; standards; Assays; Z-score; Healthy volunteers; Population

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Development of an expression results in Z-score for all assays to overcome the differences related to different immunoassays.

  up to 4 hours

• Establishment of a bank of frozen sera to further develop these standards

  up to 4 hours

Study Arms (1)

Volonteers

EXPERIMENTAL

Blood sample

Other: Blood sample

Interventions

Blood sample OTHER

Volonteers

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 )

You may not qualify if:

• 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
• Fasting extended by several days.
• Patient not affiliated to a social security system (is or should be beneficiary)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Le Kremlin-Bicêtre, 94 275, France

Location

Related Publications (6)

• 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.

  PMID: 34343107 DERIVED

• 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.

  PMID: 33420804 DERIVED

• Loeb E, El Asmar K, Trabado S, Gressier F, Colle R, Rigal A, Martin S, Verstuyft C, Feve B, Chanson P, Becquemont L, Corruble E. Nitric Oxide Synthase activity in major depressive episodes before and after antidepressant treatment: Results of a large case-control treatment study. Psychol Med. 2022 Jan;52(1):80-89. doi: 10.1017/S0033291720001749. Epub 2020 Jun 11.

  PMID: 32524920 DERIVED

• 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.

  PMID: 31504982 DERIVED

• 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.

  PMID: 28505364 DERIVED

• 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.

  PMID: 27167056 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe CHANSON, Professor

  Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 15, 2013
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

FR (1)