Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
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 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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes