Resistant Starch as a complementary treatment for type 2 diabetes

ISRCTN	ISRCTN10727538
DOI	https://doi.org/10.1186/ISRCTN10727538
Protocol serial number	8870
Sponsor	University of Surrey (UK)
Funder	Diabetes UK (UK)

Submission date: 18/11/2011
Registration date: 18/11/2011
Last edited: 21/04/2015

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
Diabetes and Endocrinology
Postgraduate Medical School
London
GU2 7WG
United Kingdom

Phone	+44 (0)148 3 68 6407
Email	m.robertson@surrey.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Scientific title	Resistant Starch as a complementary treatment for type 2 diabetes
Study acronym	DRN 505 (Resistant Starch treatment for T2DM)
Study objectives	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(s)	10/H1101/29
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	11. Glycaemic control 1.1. Hyperinsulinaemic clamp with stable isotopes 2. HbAc 3. Fasting glucose and insulin Measured at end of intervention
Key secondary outcome measure(s)	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
Completion date	29/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	01/06/2010
Date of final enrolment	29/02/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Surrey

London
GU2 7WG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	15/04/2014		Yes	No