Type 2 Diabetes Clinical Trial
— ERIEOfficial title:
Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes
Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - 40 T2D patients (20 Caucasian and 20 SAS) - 40-70 years old - Male-female - BMI 25-35 kg/m2 - Stable anti diabetic drugs for 3 months (metformin is obligatory) - Stable medication use past 3 months - Able to give informed consent Exclusion Criteria: - - Proton-pump inhibitor usage (known to effect gut microbiota) - GLP1, SGLT2i 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 <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases - Active infection - Previous intestinal (e.g., bowel resection/reconstruction) surgery - Smoking (due to its influence on gut microbiome) - Vegetarian diet (since they have different microbiota) - >6 alcohol units per day or >14 alcohol units per week - Active malignancy - HbA1c >9% (75mmol/mol) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC location AMC | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fructose on glucose metabolism | to correlate changes in oral fructose handling (measured by a fructose challenge test (AUC) with 13C6-labeled fructose in relation to metabolic effects on HOMA-IR and continuous glucose monitoring (Freestyle libre MAGE) at baseline and after 4 weeks of dietary intervention. | 4 weeks | |
Secondary | changes in microbiota composition | correlate with changes in oral/fecal microbiota composition (diversity and strain) | 4 weeks | |
Secondary | changes in (postprandial )plasma metabolites | effects of the diet on body composition (measured via bio impedance analysis). We will also collects 24h feces and urine before each study visit to determine correlate with changes in (postprandial) untargeted plasma metabolites including endogenous ethanol | 4 weeks |
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