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| [ Print-friendly version ] |
| Resistant Starch as a complementary treatment for type 2 diabetes |
| ISRCTN | ISRCTN10727538 |
| ClinicalTrials.gov identifier | |
| Public title | Resistant Starch as a complementary treatment for type 2 diabetes |
| Scientific title | |
| Acronym | DRN 505 (Resistant Starch treatment for T2DM) |
| Serial number at source | 8870 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | 10/H1101/29 |
| Study design | Randomised; Interventional; Design type: Treatment |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: Diabetic Control, Metabolic, Nutrition |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/06/2010 |
| Anticipated end date | 29/02/2012 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Interventions | Dietary Intervention, 40g/day resistant starch for weeks compared to matched placebo; Study Entry : Single Randomisation only |
| 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 |
| 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 |
| Sources of funding | Diabetes UK (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Denise Robertson |
| Address |
University of Surrey
Diabetes and Endocrinology Postgraduate Medical School |
| City/town | London |
| Zip/Postcode | GU2 7WG |
| Country | United Kingdom |
| Tel | +44 (0)148 3 68 6407 |
| m.robertson@surrey.ac.uk | |
| Sponsor | University of Surrey (UK) |
| Address |
European Institute of Health and Medical Sciences
Edward Duke Of Kent Building |
| City/town | Guildford |
| Zip/Postcode | GU2 7TE |
| Country | United Kingdom |
| Date applied | 18/11/2011 |
| Last edited | 18/11/2011 |
| Date ISRCTN assigned | 18/11/2011 |
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