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临床试验/NCT05717595
NCT05717595招募中不适用

BaRiatric Surgery AnD FRUctose Handeling In Obese subjecTs

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 20 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
20
试验地点
1
主要终点
oral fructose handling

研究概览

简要总结

To investigate whether changes in fructose dietary intake can help to improve dietary fructose-induced insulin resistance and post bariatric weight loss in obese subjects of Caucasian descent

详细描述

In this Randomized controlled trial, males and premenopausal women, scheduled for RYGB bariatric surgery at Spaarne Gasthuis of Caucasian Dutch descent, age ≥18 years will be put on either their high fructose diet (>100 gram fructose / day) versus a low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) 4 weeks before bariatric surgery. For both groups, an oral (13-C labeled) fructose challenge will be performed at baseline as well as 4 weeks after start of the diet (in the week of the surgery).

Outcome measures: Primary endpoints are changes in oral fructose induced glucose and insulin postprandial plasma excursions (measured by a fructose tolerance test with 120mg 13C6-labeled fructose in relation to long term glucose handling (HOMA and Freestyle Libre) at baseline and after 4 weeks (in the week of surgery) after both diets. Secondary endpoints are changes in histology and RNA seq gene expression in liver, adipose and jejunum tissue harvested with biopsy during bariatric surgery and changes in fecal gut microbiota composition, 24h feces and urine for fructose content and (postprandial) plasma metabolites including endogenous ethanol at both timepoints. Of note, dietary intake including fructose content will be monitored by an experienced dietician from Spaarne Gasthuis. Finally, to study relations with (long term) weight loss up to 1 year after surgery related to dietary intake, the last time points at 6 and 12 months after surgery (during regular clinical outpatient visits) will be used as an exploratory endpoint to gain more insight into the relationship between gut microbiota, (pre surgery) dietary fructose intake and weight loss after bariatric surgery.

研究设计

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

盲法说明

randomisation

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for a RYGB gastric bypass*
  • Men and premenopausal women > 18 years of age
  • Caucasian descent
  • Ability to provide written informed consent
  • * All subjects on the waiting list meet the criteria for bariatric surgery, that is:
  • BMI > 40 kg/m2 OR >35 kg/m2 with obesity related co-morbidity
  • Reasonable supervised attempts to lose weight

排除标准

  • Unstable metabolic condition defined as;
  • Diabetes with poor glycemic control (HbA1c > 8.5%);
  • Use of an antidiabetic or anti-obesity drug;
  • Malabsorptive or restrictive bariatric (weight loss) surgery in history
  • Evidence for a form of liver disease (except for NAFLD without cirrhosis)
  • Known genetic basis for insulin resistance or glucose intolerance
  • Use of certain drugs known to produce hepatic steatosis in the previous 6 months (such as oral corticosteroids, high-dose estrogens, methotrexate, tetracycline, amiodarone)
  • Malabsorptive disease orders (celiac disease, inflammatory bowel disease)
  • Use of certain drugs that may injure the lining of the intestine in the previous months (colchicine, cholestyramine)
  • Excessive alcohol intake (≥5 IU per day or ≥ 14 IU per week)
  • Recent use of antibiotics (≤ 3 months before surgery)
  • Hemostasis disorders or current treatment with anticoagulants Any primary lipid disorder
  • Unable to maintain diet intervention, or unable to reliably rapport diet

结局指标

主要结局

oral fructose handling

时间窗: 4 weeks

to correlate changes in oral fructose excursions (measured by AUC of fructose tolerance test enriched with 13C6-labeled fructose with glucose excursions (MAGE by Freestyle Libre)

次要结局

  • fructose changes in visceral organs(4 weeks up to one year)
  • metabolites(4 weeks up to one year)
  • gutmicrobiota(4 weeks up to one year)
  • weight(4 weeks up to one year)

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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