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ISRCTN
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ISRCTN08745124
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ClinicalTrials.gov identifier
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Public title
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Assessment of single-dose benzodiazepines on insulin secretion, insulin sensitivity and glucose effectiveness in healthy volunteers: a double-blind, placebo-controlled, randomised cross-over trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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UF 7546
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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France
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Disease/condition/study domain
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Beta-cell function, insulin sensitivity and glucose effectiveness
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Participants - inclusion criteria
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Healthy male volunteers aged 20-29 years
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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01/01/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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15
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Interventions
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Single infusion of diazepam (10 mg), clonazepam (1 mg) or placebo just before a frequently sampled intravenous glucose tolerance test.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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French Health Products Safety Agency (Agence française de sécurité sanitaire des produits de santé [Afssaps]) (France) - Appel d'offres 1996 de projets de recherche en pharmacologie clinique et thérapeutique
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15102335
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Contact name
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Prof
Pierre
Petit
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Address
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Centre d'Investigation Clinique - Hôpital Saint Eloi
80 avenue Augustin Fliche
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City/town
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Montpellier
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Zip/Postcode
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34295 cedex 5
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Country
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France
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Sponsor
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University Teaching Hospital of Montpellier (CHU de Montpellier) (France)
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Address
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Direction Recherche et Valorisation - Hôpital La Colombière
39 avenue Charles Flahault
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City/town
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Montpellier
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Zip/Postcode
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34295 cedex 5
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Country
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France
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Date applied
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19/12/2003
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Last edited
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29/08/2007
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Date ISRCTN assigned
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22/12/2003
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