The effect of ghrelin on gastric emptying in gastroparesis
| ISRCTN | ISRCTN11016259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11016259 |
| Secondary identifying numbers | N0515129608 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anton Emmanuel
Scientific
Scientific
Department of Gastroenterology and Nutrition
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
Study information
| Study design | Double blind placebo controlled randomised cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Ghrelin enhances gastric emptying in diabetic gastroparesis: a double blind, placebo controlled, crossover study. |
| Study objectives | We hypothesise that ghrelin stimulates gastric emptying in man. We aim to investigate whether ghrelin infusion can stimulate gastric emptying and provide a potential future treatment for diabetic gastroparesis. Information will also be obtained about: 1. Safety of intravenous ghrelin in insulin-dependent diabetes mellitus (IDDM) patients 2. Correlating gastric emptying with autonomic function 3. Baseline serum ghrelin levels in Type I diabetic patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Gastroparesis |
| Intervention | At time zero infusion will commence with either 5 pmol/kg min ghrelin or saline. This will be blinded to both patient and doctor administering the infusion. Throughout the infusion, euglycaemia will be maintained using a glycaemic clamp. Patients will omit their usual morning dose of insulin on the day of the study, since they will be fasted. Gastric emptying and accommodation will be assessed with 3D real time ultrasound scanning. Thirty minutes after the infusion has begun the subject will be given a meal of warm chicken soup and ultrasound measurements taken of the antrum and fungus taken at baseline and then 15 minutes intervals. From this the cross sectional areas can be calculated and hence the degree of gastric emptying. Small bowel transit will be calculated using the method of O'Brien et al. Blood Glucose Monitoring (BM stix) measurements will then be made every 15 minutes during the infusion to help maintain euglycaemia. 8 ml of the venous blood will be drawn immediately before the infusion, and then at 15 minutes intervals until the end of the infusion. These samples will be spun down and frozen for subsequent analysis. Blood pressure and heart rate will be recorded at 15-minute intervals throughout the study. Cardiac monitoring will continue through the whole infusion and for 30 minutes afterwards. Each subject will be asked to fill out the following questionnaires before commencement of infusion: 1. A visual analogue scale asking them to grade their upper GastroIntestinal (GI) symptoms and degree of hunger at 30 min intervals. 2. Gastric emptying data will be compared between placebo and ghrelin and for each subject using the paired Student t-test. 3. Non-parametric questionnaire data will be analysed using the Mann-Whitney U test. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ghrelin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Secondary endpoints include: 1. Alleviation of hunger scores 2. Improvement of nausea scores 3. Changes in orocaecal transit |
| Overall study start date | 01/02/2003 |
| Completion date | 09/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 16 |
| Key inclusion criteria | We will recruit 16 patients with type I diabetes mellitus from the Northwick Park Diabetic Cohort who have symptoms compatible with gastroparesis, aged 18-80 years old. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 09/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College Hospital
Department of Gastroenterology and Nutrition
London
NW1 2BU
United Kingdom
London
NW1 2BU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
North West London Hospitals 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 | 01/12/2005 | Yes | No |
Editorial Notes
04/10/2017: internal review.
