Extrait

Background and study aims Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Sugars and fats, two basic nutrients for humans are absorbed into the body in different ways. In people with T2DM there is a disturbance in the absorption of sugar and fat. As more knowledge is available about how people with T2DM respond to fatty and sugary food, there may be a better dietary advice and new products can be developed to treat this disease. The aim of this study is to examine the difference in the absorption of fats and sugars between healthy people and people with T2DM Who can participate? 20 healthy men and 20 men with T2DM, aged 30 to 70 What does the study involve? The two groups of participants attend two study days after not eating or drinking anything but water for 10 hours. At the study days, participants are randomly allocated to drink either a high fat drink or a sugary drink. Before drinking the drink and then half an hour, one, two, four, six and eight hours after drinking it, participants have samples of blood taken to assess the way that their bodies are processing the sugar or fats. In addition, half of the participants in each group have samples of breath taken using a special device which are used to measure the amount of oxygen and carbon dioxide present in order to calculate how well they are processing fats and sugars. The remaining participants have a sample of breath or saliva taken which is used to analyse their metabolism. What are the possible benefits and risks of participating? There are no notable benefits involved with participating. There is a small risk of pain and bruising when blood samples are collected. In addition, drinking the sugary drinks can sometimes cause ausea, bloating, dizziness and headache. The high-fat drink is safe, it consists of daily used food products, but can also give nausea and bloating. Where is the study run from? Centre for Human Drug Research (Netherlands) When is the study starting and how long is it expected to run for? July 2012 to January 2013 Who is funding the study? 1. Ministry of Economic Affairs (Netherlands) 2. ABBOTT Nutrition (Netherlands) 3. Friesland Campina (Netherlands) 4. Danisco-DuPont (Netherlands) 5. DSM (Netherlands) 6. Nestlé (Netherlands) Who is the main contact? Dr Suzan Wopereis

Critère d'inclusion

• Type 2 diabetes mellitus

Liens

• isrctn