Contact information
Type
Scientific
Primary contact
Dr Denise Robertson
ORCID ID
Contact details
University of Surrey
Postgraduate Medical School
Stirling Road
Guildford
GU2 7DJ
United Kingdom
+44 1483 68 6407
m.robertson@surrey.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11066
Study information
Scientific title
Do gut bacteria have a role in the aetiology of type 2 diabetes?
Acronym
Study hypothesis
Animal models have clearly demonstrated that gut bacteria can be linked to changes in the permeability of the intestine and may be responsible for some of the clinical features associated with type 2 diabetes. This will be the first attempt to translate these findings into human volunteers and patients.
The main objectives of this study are to
1. Assess whether colonic microflora, intestinal permeability, and endotoxaemia (plasma levels of lipopolysaccharide) in patients with type 2 diabetes differ from those of matched obese and lean subjects
2. To assess whether manipulation of colonic microflora with prebiotic carbohydrate supplement improves glucose tolerance via improvements in intestinal permeability and endotoxaemia.
Ethics approval
First MREC, 06/09/2011, ref: 11/LO/1141
Study design
Interventional randomised treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes Type 2
Intervention
We will recruit 30 patients with type 2 diabetes in addition to 30 healthy controls in which we will characterise gut bacteria, measure intestinal permeability non-invasively and look for signs of inflammation. For healthy subjects, this involves three visits to the Royal Surrey County hospital for screening and a blood test, permeability test (ingestion of 51Cr-EDTA in water followed by 24h urine collection), and return of urine collection and a stool sample.
In addition in the patient group, we will use a 12-week dietary intervention using prebiotic fibre to directly change the bacterial composition, to investigate whether this has any beneficial effects on glycaemic control. Following the 3 visits for baseline measurements, which also includes an IVGTT test for insulin secretion for this group, the patients will be randomised to either prebiotic treatment (galacto-oligosachharide 5g/day) or placebo (maltodextrin 5g/day). On the completion of the dietary intervention, patients will return to the hospital for another two visits for an intestinal permeability test and return of 24 hour urine collection and a stool sample and an IVGTT test
Prebiotic, randomization to either prebiotic carbohydrate supplement 5g, or maltodextrin as a placebo, daily for 12 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Inflammatory markers measured at baseline and after 12 weeks intervention
Secondary outcome measures
1. Gut bacteria measured at at baseline and after 12 week intervention
2. Insulin secretion measured at baseline and after 12 weeks intervention
3. Intestinal permeability measured at baseline and after 12 weeks intervention
4. Plasma endotoxin measured at baseline and after 12 weeks intervention
Overall trial start date
01/01/2012
Overall trial end date
30/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male
2. Aged 40-65
3. With or without Type 2 diabetes
4. Appropriate renal function
Participant type
Patient
Age group
Neonate
Gender
Male
Target number of participants
UK Sample Size: 60; Description: 30 control subjects and 30 patients with type 2 diabetes
Participant exclusion criteria
1. Female
2. History of bowel disease
3. Abnormal renal function
4. Use of antibiotics in preceding 3 months
5. Regular use of NSAID medication
6. Use of diuretics
Recruitment start date
01/01/2012
Recruitment end date
30/09/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Surrey
Guildford
GU2 7DJ
United Kingdom
Sponsor information
Organisation
University of Surrey (UK)
Sponsor details
Wolfson Unit for Translational Research
Diabetes and Endocrinology
Daphne Jackson Road
Guildford
GU2 7WG
United Kingdom
+44 (0)1483 300800
m.robertson@surrey.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Foundation for the study of Diabetes (EU)
Alternative name(s)
EFSD
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list