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Effect of diEtaRy fructose on fructose kinetics in type 2 dIabetEs

Effect of diEtaRy fructose on fructose kinetics in type 2 dIabetEs - ERIE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51729
Enrollment
40
Registered
2022-10-14
Start date
2022-10-28
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sugar disease Type 2 Diabetes

Interventions

High (100gr/day) vs Low (30gr/day) fructose diet for 4 weeks. Fructose will be ingested via regular dietary route (food/drink changes) and the process will be monitored by a dietician.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026