|
ISRCTN
|
ISRCTN11016259
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effect of ghrelin on gastric emptying in gastroparesis
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0515129608
|
|
Study hypothesis
|
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
|
Not provided at time of registration
|
|
Study design
|
Double blind placebo controlled randomised cross-over study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Digestive System: Gastroparesis
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/02/2003
|
|
Anticipated end date
|
09/09/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
16
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Secondary endpoints include:
1. Alleviation of hunger scores
2. Improvement of nausea scores
3. Changes in orocaecal transit
|
|
Sources of funding
|
North West London Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16085693
|
|
Contact name
|
Dr
Anton
Emmanuel
|
|
Address
|
Department of Physiology
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
|
|
City/town
|
Harrow, Middlesex
|
|
Zip/Postcode
|
HA1 3UJ
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
30/04/2008
|
|
Date ISRCTN assigned
|
12/09/2003
|
