| Source of record | UK Trials |
| ISRCTN | ISRCTN50808730 |
| Date ISRCTN assigned | 21/02/2008 |
| Local reference number(s) | RGHT000460 |
| Public title | Comparison of 15% versus 5% sucrose intakes as part of a eucaloric diet in overweight/obese subjects: impact on insulin resistance, insulin secretion, postprandial glucose levels and vascular compliance |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Overweight/obesity and risk of type 2 diabetes mellitus |
| Study hypothesis | 15% sucrose intake is detrimental to insulin action when compared to 5% sucrose intake as part of a eucaloric diet in overweight/obese individuals. |
| Design/methodology | Randomised cross-over trial |
| Research ethics review | Ethics approval received from the Regional Ethics Committee for Northern Ireland on the 30th October 2007 (ref: HSC REC 3 - REC number 07/NIR03/93). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy male and female volunteers
2. Overweight/obese (Body Mass Index [BMI] 25 - 35 kg/m^2)
3. Over 18 years old |
| Participants - exclusion criteria | 1. A history of cardiac, hepatic or renal disease
2. Due to the use of radioisotopes, women of child bearing age will be excluded unless they are taking effective contraceptive precautions |
| Patient information material |
|
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/08/2009 |
| Status of trial | Ongoing |
| Target number of participants | 12 - 15 |
| Interventions | Each subject will undergo two dietary intervention periods, each six weeks long separated by a four week washout period. Both diets are matched for macronutrient profile and differ in their micronutrient profile, in that one will have 5% sucrose and the other 15% sucrose content. |
| Primary outcome measure(s) | Insulin resistance, assessed at the end of each six week dietary period using the euglycaemic hyperinsulinaemic glucose clamp technique. |
| Secondary outcome measure(s) | 1. Glucose tolerance tests, performed at the beginning and end of each six week dietary period to assess postprandial glucose levels and insulin secretion
2. Plasma lipids
3. Vascular compliance; pulse wave analysis will be done at the beginning and end of each dietary period to assess vascular compliance
4. Glycaemic control
5. Blood pressure |
| Sources of funding | 1. The Sugar Bureau (UK)
2. Northern Ireland Research and Development Office (UK) |
| Sponsor name | Belfast Health and Social Care Trust (UK) |
| Sponsor details | (at the Royal Hospitals site)
Royal Victoria Hospital
Grosvenor Road
Belfast
United Kingdom
BT12 6BA |
| Sponsor website | http://www.belfasttrust.hscni.net/ |
| Contact name | Dr Steven Hunter |
| Contact details | The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
United Kingdom
BT12 6BA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN50808730 |
| Date last extracted from ISRCTN register | 17/04/2008 |
