Effect of Testosterone replacement on glycaemic control and insulin sensitivity in hypogonadal men with type 2 diabetes
| ISRCTN | ISRCTN57267165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57267165 |
| Secondary identifying numbers | N0034128967 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/11/2008
- 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
Dr TH Jones
Scientific
Scientific
Medicine
Barnsley District General Hospital NHS Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To assess the effect of testosterone on glycaemic control and insulin sensitivity in type 2 diabetic men with hypogonadism. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Hypogonadism |
| Intervention | Testosterone replacement vs placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Testosterone |
| Primary outcome measure | Efficacy of testosterone replacement |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2003 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 20 male patients |
| Key inclusion criteria | Diabetic men above 30 yrs old with hypogonadism |
| Key exclusion criteria | Hormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medicine
Barnsley
S75 2EP
United Kingdom
S75 2EP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Barnsley Hospital NHS Foundation Trust (UK), BDGH Small Projects Fund (internal funding)
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 | 01/06/2006 | Yes | No |
