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临床试验/NCT05717608
NCT05717608招募中不适用

Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
fructose on glucose metabolism

研究概览

简要总结

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.

详细描述

The prevalence and accompanying morbidity and mortality of obesity and type 2 diabetes (T2D) is increasing on a global scale. Unfortunately the underlying (patho)physiological mechanisms are only partially understood. A key step in the development of negative health effects of metabolic disease might be via dietary fructose metabolism and its accompanying aberrant metabolite production, in which our gut microbiota plays a crucial role.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

supplementation with either fructose or dextrose

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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)

结局指标

主要结局

fructose on glucose metabolism

时间窗: 4 weeks

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.

次要结局

  • changes in microbiota composition(4 weeks)
  • changes in (postprandial )plasma metabolites(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Max Nieuwdorp

professor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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