Effects of Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) on insulin secretion and energy balance in human obesity and diabetes

ISRCTN	ISRCTN19339824
DOI	https://doi.org/10.1186/ISRCTN19339824
Secondary identifying numbers	N0207174689

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 28/09/2011

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 L R Ranganath
Scientific

Dept. of Clinical Chemistry
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Phone	+44 0151 706 4197
Email	lrang@liv.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
Primary outcome measure	Role of GIP and GLP-1 in diabetes and obesity
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2004
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	6
Key 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.
Key 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)
Date of first enrolment	01/09/2004
Date of final enrolment	01/09/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept. of Clinical Chemistry

Liverpool
L7 8XP
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Liverpool and Broadgreen University Hospitals Trust (UK), RLUH R&D Trust Fund,

No information available

NHS R&D Support Funding.

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	01/08/2009		Yes	No