Effects of fatty acids on postprandial inflammatory response van healthy obese and type 2 diabetic obese subjects - PIFA study (Study on Postprandial Inflammation and Fatty Acids)

Wageningen Universiteit0 个研究点目标入组 66 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Inclusion criteria for all participants:
•- male gender
•-50-70 yrs
•For diabetic patients only:
•- BMI >30 kg/m2
•- Well-controlled diabetes: fasting plasma glucose concentration must be <10.0 mmol/l at the time of screening.
•- Must be on sulphonylurea- or metformin therapy for at least 6 months with a constant dose for at least two months, or on dietary treatment for at least 6 months2.
•For obese controls only:
•- BMI > 30 kg/m2
•- normoglycemic according to WHO criteria (OGTT, fasting blood glucose< 7 mmol/L, after 2 hr <7.8mmol/L)
•For lean controls only:
•- BMI 18-25 kg/m2
•- normoglycemic according to WHO criteria (OGTT, fasting blood glucose< 7 mmol/L, after 2 hr <7.8mmol/L)

•Exclusion criteria for all participants:
•All subjects:
•- Female gender
•- Age below 50 or above 70 years
•- Hemoglobin levels <8.4 mmol/L
•- Allergic to cow milk or dairy products
•- Allergic to fish oil
•- Vegetarian
•- Tobacco smoker
•- Current or recent (<4 weeks) use of fish oil supplements or more then four times fish/week; 24.35 g of EPA-DHA of fish per month (800 mg/day) as judged by the questionnaire.
•- Received inoculations within 2 months of starting the study or planned to during the study
•- Donated or intended to donate blood from 2 months before the study till two months after the study
•- Unstable body weight (weight gain or loss > 3 kg in the past three months)
•- Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, gastrointestinal disease, renal dysfunction)
•- Use of medications know to interfere with glucose homeostasis (i.e. corticosteroids)
•- abuse of drugs and/or alcohol
•- participation in another biomedical study within 1 month before the first screening visit;For obese, type 2 diabetic subjects only:
•- severe diabetes which requires application of insulin
•- diabetes-related complications
•For obese subjects and lean controls only:
•- hyperglycemic according to WHO criteria (OGTT, fasting blood glucose >6.0mM, after 2 hr>11mM)
•-systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg
•- Urinary glucose concentrations (>0.25 g/l)

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