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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
ISRCTN ISRCTN50808730
DOI 10.1186/ISRCTN50808730
ClinicalTrials.gov identifier
EudraCT number
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
Serial number at source RGHT000460
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.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design Randomised cross-over trial
Countries of recruitment United Kingdom
Disease/condition/study domain Overweight/obesity and risk of type 2 diabetes mellitus
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
Anticipated start date 01/11/2007
Anticipated end date 01/08/2009
Status of trial Completed
Patient information material
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)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23363580
Contact name Dr  Steven  Hunter
  Address The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
Sponsor Belfast Health and Social Care Trust (UK)
  Address (at the Royal Hospitals site)
Royal Victoria Hospital
Grosvenor Road
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
  Sponsor website: http://www.belfasttrust.hscni.net/
Date applied 31/10/2007
Last edited 28/06/2013
Date ISRCTN assigned 21/02/2008
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