The nutritional, cardiovascular and immunological effect of daily subcutaneous ghrelin in dialysis patients with evidence of malnutrition
| ISRCTN | ISRCTN43319045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43319045 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/03/2006
- Registration date
- 22/06/2006
- Last edited
- 20/01/2011
- 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 Peter Choi
Scientific
Scientific
West London Renal and Transplant Centre
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Study design | Randomised, double-blind, placebo-controlled, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Ghrelin treatment has beneficial effects on the disordered nutritional, cardiovascular and immunological physiology of dialysis patients. |
| Ethics approval(s) | Approved by the Riverside Research Ethics Committee on 01/02/2006, reference number: 05/Q0401/132 |
| Health condition(s) or problem(s) studied | Malnutrition or renal failure |
| Intervention | Subcutaneous ghrelin versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ghrelin |
| Primary outcome measure | 1. Blood pressure 2. Energy expenditure 3. Cytokine production |
| Secondary outcome measures | 1. Food intake 2. Nutritional parameters |
| Overall study start date | 13/03/2006 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Dialysis patients at West London Renal and Transplant Centre, Hammersmith Hospital with evidence of malnutrition |
| Key exclusion criteria | 1. Anaemia 2. Over 75 years of age 3. Recent illness |
| Date of first enrolment | 13/03/2006 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West London Renal and Transplant Centre
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Hammersmith Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Du Cane Road
London
W12 0HS
England
United Kingdom
| Website | http://www.hhnt.org/trust/index.htm |
|---|---|
"ROR" |
https://ror.org/05jg8yp15 |
Funders
Funder type
Government
Hammersmith Hospital NHS Trust (UK)
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 | 01/07/2009 | Yes | No |
