Status:
COMPLETED
Establishment of Reference Values for Insulin-like Growth Factor 1 (IGF1) in the General Population
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Population
Eligibility:
All Genders
18-89 years
Phase:
NA
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 ...
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....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
924 Patients enrolled
Trial Details
Trial ID
NCT01831648
Start Date
May 1 2010
End Date
April 1 2012
Last Update
April 15 2013
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris
Le Kremlin-Bicêtre, France, 94 275