Contact information
Type
Scientific
Primary contact
Dr L R Ranganath
ORCID ID
Contact details
Dept. of Clinical Chemistry
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 0151 706 4197
lrang@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0207174689
Study information
Scientific title
Acronym
Study hypothesis
1. Are both GIP and GLP-1 necessary for optimal insulin secretion in healthy and diabetic subjects?
2. Do both GIP and GLP-1 have an effect on energy balance and appetite?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
At the baseline assessment visit, eligibility will be confirmed, subjects will be weighed, height recorded, and waist circumference measured. Body composition will be measured by electrical bio impedance (Tanita 310). Thereafter, 4 half day studies are required for measurements of insulin secretion during infusion of GLP-1 alone, GIP alone, GLP-1 and GIP together and placebo. Because GLP-1 and GIP augment glucose-stimulated insulin secretion will be determined in response to co-infusion of 10% glucose during each experiment by serial blood sampling. Throughout these experiments, resting metabolic rate will be measured at baseline and then hourly (for postprandial thermogenesis) by indirect calorimetry, using the Deltatrack II system. Effects on hunger and satiety will be determined from concomitant visual analogue hunger scores taken at baseline and then hourly. Ad libitum food intake will be assessed with test meal at lunchtime. The studies will be completed once lunch is consumed. A total of 48 studies will be undertaken. GLP-1/GIP peptides: GLP-1 and GIP has been obtained from Polypeptide Laboratories (Germany) and sterile-filtered by Stockport Pharmaceuticals (Stebbing Hill Hospital, Stockport). In preliminary work with synthetic peptides in non diabetic subjects we have found infusion of GLP-1 at rates of 1pmol/kg/min to be well tolerated without side effects, and to result in highly significant and sustained elevations in plasma insulin and C peptide concentrations. Steady states of insulin are reached after 60 minutes of infusion at this rate. Glucose profiles in plasma were maintained in the euglycaemic range during the combined infusion of dextrose and GLP-1 (unpublished).
Intervention type
Drug
Phase
Not Specified
Drug names
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
Primary outcome measures
Role of GIP and GLP-1 in diabetes and obesity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2004
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Obese male subjects between age 20-60 years will be recruited by advertisement and by invitation of eligible patients who have already undergone glucose tolerance testing. This is a pilot study and will involve the following groups. 6 lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance and 6 obese (BMI >30 kg/m2) type-2 diabetic patients on treatment with diet alone. Eligible subjects will be asked to provide informed written consent, and studies will be undertaken in accordance with the Declaration of Helsinki.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
6
Participant exclusion criteria
Any co-morbid conditions requiring drug therapy that cannot be discontinued, any regular drug treatment that cannot be discontinued, any diseases of the heart, lungs, liver, gut or endocrine glands, alcoholism, eating disorder, and for the diabetic group - poorly controlled diabetes (defined as HbAlc >8.0% for the purposes of this study)
Recruitment start date
01/09/2004
Recruitment end date
01/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept. of Clinical Chemistry
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Liverpool and Broadgreen University Hospitals Trust (UK), RLUH R&D Trust Fund,
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding.
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19178509
Publication citations
-
Results
Daousi C, Wilding JP, Aditya S, Durham BH, Cleator J, Pinkney JH, Ranganath LR, Effects of peripheral administration of synthetic human glucose-dependent insulinotropic peptide (GIP) on energy expenditure and subjective appetite sensations in healthy normal weight subjects and obese patients with type 2 diabetes., Clin. Endocrinol. (Oxf), 2009, 71, 2, 195-201, doi: 10.1111/j.1365-2265.2008.03451.x.