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 |
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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
Scientific
Dept. of Clinical Chemistry
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Phone | +44 0151 706 4197 |
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lrang@liv.ac.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
L7 8XP
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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? |
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Results article | results | 01/08/2009 | Yes | No |