Insulin resistance/type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteer aged greater than or equal to 18 years 2. Used to eat breakfast (solid food) 3. Not involved in intensive sportive activities more than once a week (e.g. playing football, tennis, running, race-cycling, swimming) 4. Stable weight and no intention to loose weight until completion of the study
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus 2. Gastrointestinal disorders (including constipation) 3. Body mass index (BMI) less than 18 or greater than 25 kg/m2 4. Not being able to fast overnight (12 hours) 5. Intake of medication 6. Undergone digestive tract surgery (except appendectomy) 7. Inflammatory disease (possibly interfering with measurement of parameters in this study) 8. Donation of blood (greater than 500 ml) within the last 3 months prior to admission to the clinic 9. Participation to another clinical study within 90 days before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose kinetics of the test meals, such as the rate of appearance of exogenous glucose in plasma. Glucose kinetics is calculated using total plasma glucose concentration, the 13C/12C-ratio of glucose in plasma samples, and the 2H/1H-glucose ratio in plasma samples. Plasma samples were drawn at the following timepoints (in minutes, at t = 0 the test meal was consumed): -60, -30, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300, 330, 360. Plasma concentrations of total blood glucose and insulin are also considered as primary outcome measures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentrations of incretins and markers of inflammation 2. Sensation of appetite and satiety (VAS registration) as well as feeling and extent of discomfort after consumption of the test meal 3. Demographic and other parameters include 3.1. Body weight 3.2. Body mass index (BMI) 3.3. Family history of T2DM 3.4. Habitual diet 3.5. Smoking habits 3.6. Sportive activities | — |
Countries
Netherlands