Bacteria and glucose control

ISRCTN	ISRCTN07813749
DOI	https://doi.org/10.1186/ISRCTN07813749
Secondary identifying numbers	11066

Submission date: 11/04/2012
Registration date: 11/04/2012
Last edited: 21/01/2019

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 Denise Robertson
Scientific

University of Surrey
Postgraduate Medical School
Stirling Road
Guildford
GU2 7DJ
United Kingdom

Phone	+44 1483 68 6407
Email	m.robertson@surrey.ac.uk

Study information

Study design	Interventional randomised treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Do gut bacteria have a role in the aetiology of type 2 diabetes?
Study objectives	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(s)	First MREC, 06/09/2011, ref: 11/LO/1141
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2012
Completion date	30/09/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Male
Target number of participants	UK Sample Size: 60; Description: 30 control subjects and 30 patients with type 2 diabetes
Key inclusion criteria	1. Male 2. Aged 40-65 3. With or without Type 2 diabetes 4. Appropriate renal function
Key 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
Date of first enrolment	01/01/2012
Date of final enrolment	30/09/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7DJ
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

Wolfson Unit for Translational Research
Diabetes and Endocrinology
Daphne Jackson Road
Guildford
GU2 7WG
England
United Kingdom

Phone	+44 (0)1483 300800
Email	m.robertson@surrey.ac.uk
Website	http://www.surrey.ac.uk/
"ROR"	https://ror.org/00ks66431

Funders

Funder type

Government

European Foundation for the study of Diabetes (EU)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): The European Association for the Study of Diabetes, EFSD
Location: Germany

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	01/12/2016	21/01/2019	Yes	No
Results article	results of the potential link between glucose control, intestinal permeability, diet and intestinal microbiota in patients with Type 2 Diabetes,	01/04/2018	21/01/2019	Yes	No
Results article	results of the potential relationship between gut barrier function (gut permeability) and concentration of serum lipids and lipoproteins,	01/12/2018	21/01/2019	Yes	No

Editorial Notes

21/01/2019: Publication references added
06/12/2016: No publications found in PubMed, verifying study status with principal investigator.