Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UF 7546
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Beta-cell function, insulin sensitivity and glucose effectiveness
Intervention
Single infusion of diazepam (10 mg), clonazepam (1 mg) or placebo just before a frequently sampled intravenous glucose tolerance test.
Intervention type
Drug
Phase
Not Specified
Drug names
Diazepam, clonazepam
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy male volunteers aged 20-29 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
15
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
01/01/2003
Locations
Countries of recruitment
France
Trial participating centre
Centre d'Investigation Clinique - Hôpital Saint Eloi
Montpellier
34295 cedex 5
France
Funders
Funder type
Government
Funder name
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
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15102335
Publication citations
-
Results
Chevassus H, Mourand I, Molinier N, Lacarelle B, Brun JF, Petit P, Assessment of single-dose benzodiazepines on insulin secretion, insulin sensitivity and glucose effectiveness in healthy volunteers: a double-blind, placebo-controlled, randomized cross-over trial [ISRCTN08745124]., BMC Clin Pharmacol, 2004, 4, 3, doi: 10.1186/1472-6904-4-3.