Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/04/2012
Date assigned
11/04/2012
Last edited
06/12/2016
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 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 measures

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

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

http://www.surrey.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/12/2016: No publications found in PubMed, verifying study status with principal investigator.