diabetes Diabetes Mellitus
Conditions
Interventions
Eating three standardized meals with a known composition on set time points.
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent obtained before start of the trial - Diagnosed with diabetes type 1 or type 2 for at least 1 year - Age * 18 years and * 85 years - If using mealtime insulin, able and willing to perform 6 finger prick measurements for determining blood glucose as per protocol - Able and willing to eat 3 main meals on the trial day - Able and willing to fill out an emotional state questionnaire and a stress questionnaire
Exclusion criteria
Exclusion criteria: - HbA1c > 75 mmol/mol - For diabetes type 1 patients: BMI > 27.5 - For diabetes type 1 patients: Total Daily Insulin Dosage/kg > 0.8 U/kg/day - Renal dysfunction: eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the collection of 47 samples of blood for the determination of insulin and glucose concentrations at specific time points after eating a standardized meal, while also recording the time and dosage of the patient*s diabetes medication (either insulin or metformin). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Age - Gender - Body weight - Length - BMI - Waist circumference - Waist-to-hip ratio - Average total daily insulin dosage (if applicable) - HbA1c - Cholesterol - Triglycerides - HDL - LDL - Time of diagnosis - Co-medication For the HDL study: - Oxidized phospholipids - Glycerol - Saturated fatty acids - Mono-unsaturated fatty acids - Poly-unsaturated fatty acids - Apolipoproteins: A1, A2, B48, B100, E - HsCRP - Smoking: yes or no and number of cigarettes per day - Alcohol intake: number of glasses per week - Hours of physical exercise per week | — |
Countries
Netherlands
Outcome results
None listed