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PopulationVARIETENCT01831648

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

A study testing Blood sample in people with Population, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Population
What is being tested?
Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
924 participants
Where
1 siteFrance
Study dates
May 2010to Apr 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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 )

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Assistance Publique - Hôpitaux de Paris

    Le Kremlin-Bicêtre, 94 275

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Population
Being tested
Blood sample
Keywords
IGF1, standards, Assays, Z-score, Healthy volunteers, Population

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleOther

Study groups in NCT01831648
Study groupRoleWhat they receive
VolonteersExperimentalBlood sample
Receives: Other: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 4 hours

Secondary outcomes (2)

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

    Measured: up to 4 hours

  2. Establishment of a bank of frozen sera to further develop these standards

    Measured: up to 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
924 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831648
Sponsor's protocol ID
P081216
Acronym
VARIETE
Status last verified
Apr 2013
First submitted
3 Apr 2013
Last updated
15 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34343107

  • 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.

    PubMed 33420804

  • 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.

    PubMed 32524920

  • 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.

    PubMed 31504982

  • 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.

    PubMed 28505364

  • 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.

    PubMed 27167056

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample in people with Population, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of IGF1 in serum (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831648, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.

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