Impact of dietary fructose on metabolism in type 2 diabetes
Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes
This study is testing how eating different amounts of fructose affects metabolism in people with type 2 diabetes, focusing on those of South-Asian Surinamese and Caucasian backgrounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05717608 on ClinicalTrials.gov |
What this trial studies
This study investigates how different levels of dietary fructose affect its metabolism in individuals with type 2 diabetes, specifically focusing on those of South-Asian Surinamese (SAS) and Caucasian descent. Participants will be randomized to follow either a high fructose diet (100 grams per day) or a low fructose diet (less than 30 grams per day, with isocaloric correction using dextrose) for four weeks. The study aims to understand the physiological and microbial processes involved in fructose catabolism and how these may differ between the two ethnic groups. By utilizing stable isotope techniques, researchers will measure fructose fluxes to gain insights into the metabolic implications of fructose consumption in diabetes.
Who should consider this trial
Good fit: Ideal candidates include type 2 diabetes patients aged 40-70 years, of either Caucasian or South-Asian Surinamese descent, with a BMI between 25-35 kg/m2.
Not a fit: Patients with chronic illnesses, recent antibiotic use, or those on specific medications that affect gut microbiota may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored dietary recommendations for managing type 2 diabetes based on individual metabolic responses to fructose.
How similar studies have performed: While the specific focus on fructose metabolism in these ethnic groups may be novel, previous studies have indicated that dietary interventions can significantly impact metabolic health in diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Amsterdam
- Amsterdam UMC location AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: max nieuwdorp — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: cengiz callender, MD
- Email: c.callender@amsterdamumc.nl
- Phone: 0031 20 5669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.