Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes
NCT ID: NCT05717608
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-02-05
2026-04-30
Brief Summary
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Detailed Description
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By bypassing the normal glucose metabolism pathway, fructose plays a role in the development of metabolic disease such as diabetes en fatty liver disease. The mechanism of this effect is unclear and possibly plays in the observation of ethnic specific metabolic risk factors. That is, subjects of different ethnicties (for instance South-Asian Surinamese (SAS)) have a higher risk and worse trajectory of metabolic diseases than Caucasians. Since gut microbiota is altered between these two ethnicities, we hypothesize that aberreant fructose catabolism in patients of SAS descent results in production of specific (gut microbiota derived) metabolites such as ethanol. In this study, fructose metabolism will thus be studied in patients of SAS and Caucasian Dutch descent. To this end the investigators will examine (13C stable isotope based) fructose fluxes before and after randomizing subjects into a four-week high- or low fructose diet. This study aims to elucidate the physiological and microbial catabolism of fructose and possible differences between these two ethnicities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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high fructose in caucasian dutch type 2 diabetes subjects
high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity.
high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
oral ingestion of food supplement for 4 weeks
low fructose in caucasian dutch type 2 diabetes subjects
low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity.
high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
oral ingestion of food supplement for 4 weeks
high fructose in surinamese asian type 2 diabetes
high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of SAS ethnicity.
high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
oral ingestion of food supplement for 4 weeks
low fructose in surinamese asian type 2 diabetes
low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of SAS ethnicity.
high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
oral ingestion of food supplement for 4 weeks
Interventions
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high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
oral ingestion of food supplement for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
40 Years
70 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Max Nieuwdorp
professor
Principal Investigators
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max nieuwdorp
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Amsterdam UMC location AMC
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022.0606 - NL82353.018.22
Identifier Type: -
Identifier Source: org_study_id
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