Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2003
Date assigned
22/12/2003
Last edited
29/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pierre Petit

ORCID ID

Contact details

Centre d'Investigation Clinique - Hôpital Saint Eloi
80 avenue Augustin Fliche
Montpellier
34295 cedex 5
France

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

Sponsor information

Organisation

University Teaching Hospital of Montpellier (CHU de Montpellier) (France)

Sponsor details

Direction Recherche et Valorisation - Hôpital La Colombière
39 avenue Charles Flahault
Montpellier
34295 cedex 5
France

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes