Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anton Emmanuel

ORCID ID

Contact details

Department of Gastroenterology and Nutrition
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515129608

Study information

Scientific title

Ghrelin enhances gastric emptying in diabetic gastroparesis: a double blind, placebo controlled, crossover study.

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Ghrelin

Primary outcome measures

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 trial start date

01/02/2003

Overall trial end date

09/09/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

09/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology and Nutrition,
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

North West London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16085693

Publication citations

  1. Results

    Murray CD, Martin NM, Patterson M, Taylor SA, Ghatei MA, Kamm MA, Johnston C, Bloom SR, Emmanuel AV, Ghrelin enhances gastric emptying in diabetic gastroparesis: a double blind, placebo controlled, crossover study., Gut, 2005, 54, 12, 1693-1698, doi: 10.1136/gut.2005.069088.

Additional files

Editorial Notes