sugar disease Type 2 Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - 40 T2D patients (20 Caucasian and 20 SAS) - 40-70 years - BMI 25-35 - Stable anti diabetic drugs for 3 months (metformin is obligatory) - Stable medication uses past 3 months - Able to give informed consent
Exclusion criteria
Exclusion criteria: - Proton-pump inhibitor usage (known to effect gut microbiota) - GLP1 or insulin use (known to effect gut microbiota) - Antibiotic for the past 3 months (known to effect gut microbiota) - Probiotic or symbiotic usage (known to effect gut microbiota) - Pregnant women - Chronic illness (including a known history of heart failure, renal failure (eGFR 6 alcohol units per day or >14 alcohol units per week - Active malignancy - HbA1c >9% (75mmol/mol) - The subject is already involved in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are changes in oral fructose handling (measured by a fructose tolerance test with 120mg 13C6 -labeled fructose in relation to other metabolic effects (eg on lipids, HOMA and continuous glucose monitoring Freestyle libre) at baseline and after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in gutmicrobiota composition between individuals of SAS or Caucasian descent on high versus low fructose diet. Also, effects on body composition (measured via bio impedance analysis) and 24h feces and urine for fructose content and compliance will be studied. Finally, (postprandial) untargeted plasma metabolites including endogenous ethanol at both timepoints will be done to identify involved metabolic pathways. | — |
Countries
Netherlands