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
| ISRCTN | ISRCTN08745124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08745124 |
| Secondary identifying numbers | UF 7546 |
- Submission date
- 19/12/2003
- Registration date
- 22/12/2003
- Last edited
- 29/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Pierre Petit
Scientific
Scientific
Centre d'Investigation Clinique - Hôpital Saint Eloi
80 avenue Augustin Fliche
Montpellier
34295 cedex 5
France
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Diazepam, clonazepam |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 15 |
| Key inclusion criteria | Healthy male volunteers aged 20-29 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- France
Study participating centre
Centre d'Investigation Clinique - Hôpital Saint Eloi
Montpellier
34295 cedex 5
France
34295 cedex 5
France
Sponsor information
University Teaching Hospital of Montpellier (CHU de Montpellier) (France)
Hospital/treatment centre
Hospital/treatment centre
Direction Recherche et Valorisation - Hôpital La Colombière
39 avenue Charles Flahault
Montpellier
34295 cedex 5
France
"ROR" |
https://ror.org/00mthsf17 |
|---|
Funders
Funder type
Government
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
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 04/03/2004 | Yes | No |
