Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/11/2011
Date assigned
18/11/2011
Last edited
21/04/2015
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
Diabetes and Endocrinology
Postgraduate Medical School
London
GU2 7WG
United Kingdom
+44 (0)148 3 68 6407
m.robertson@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8870

Study information

Scientific title

Resistant Starch as a complementary treatment for type 2 diabetes

Acronym

DRN 505 (Resistant Starch treatment for T2DM)

Study hypothesis

Dietary fibres in the diet, such as resistant starch, are known to have many health benefits especially regarding large-bowel health. Resistant starch is of particular interest as it can be easily incorporated into everyday foods without affecting the appearance, taste or texture of that food. Fibres are fermented in the large-bowel by the resident bacteria releasing metabolites known as short-chain fatty acids. These short-chain fatty acids are absorbed into the general circulation and are believed to underlie the other health benefits of dietary fibre, namely increasing the bodies' responsiveness to the hormone insulin and so reducing the risk of developing conditions such as high blood-pressure, type 2 diabetes and heart disease.

Initial studies in our group have shown that resistant starch has beneficial effects on the insulin response in healthy subjects and those at risk of developing diabetes. Due to these findings the current study has been designed to look at the effects of resistant starch in subjects who have well controlled type 2 diabetes and investigate whether there is an improvement in glycaemic control when resistant starch is consumed in addition to an individual's normal diet and treatment.

Participants will be asked to consume the resistant starch or an energy and carbohydrate matched placebo everyday for 12 weeks. At the end of each 12 week period the participants will be asked to attend for 3 study visits where the effects on glycaemic control, insulin sensitivity and body fat storage (by MRI scanning) will be assessed.

The overall aim of the study is to conduct a placebo-controlled crossover dietary intervention study using 40 g/day RS for 12 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM).
The following measurements will be taken and compared between the interventions:
1. Isulin sensitivity
2. Changes to glycaemic control
3. HbA1c, fasting insulin sensitivity by homeostatic model assessment (HOMA), plasma lipids

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8870

Ethics approval

10/H1101/29

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: Diabetic Control, Metabolic, Nutrition

Intervention

Dietary Intervention, 40g/day resistant starch for weeks compared to matched placebo; Study Entry : Single Randomisation only

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

11. Glycaemic control
1.1. Hyperinsulinaemic clamp with stable isotopes
2. HbAc
3. Fasting glucose and insulin
Measured at end of intervention

Secondary outcome measures

1. Ectopic fat distribution
1.1. Whole body magnetic resonance imaging (MRI)
2. Vascular function
2.1. Blood pressure and pulse wave analysis
Measured at end of intervention

Overall trial start date

01/06/2010

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and Females, aged 20 - 65 years
2. Those with T2DM, that has been diagnosed for > 2 years, and
3. Are either diet / exercise controlled or on metformin treatment (or both), which has not been modified in 6 months.
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 20 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. Those who control their diabetes by insulin or sulphonylureas
2. Those with an HbA1c >= 8.5 indicative of poor control
3. Those with certain medical conditions (for example heart disease, gastrointestinal disease, liver disease, type 1 diabetes or endocrine diseases)
4. Those know to suffer from claustrophobia or have metal implants as this would prevent Magnetic resonance spectroscopy (MRS) scanning

Recruitment start date

01/06/2010

Recruitment end date

29/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
London
GU2 7WG
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

European Institute of Health and Medical Sciences
Edward Duke Of Kent Building
Guildford
GU2 7TE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24671124

Publication citations

Additional files

Editorial Notes