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 |
| Protocol serial number | UF 7546 |
| Sponsor | University Teaching Hospital of Montpellier (CHU de Montpellier) (France) |
| Funder | 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 |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Diazepam, clonazepam |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
