Effects of fatty acids on postprandial inflammatory response van healthy obese and type 2 diabetic obese subjects
- Conditions
- 10018424obese en gezonde vrijwilligersthe molecular and biochemical mechanism of fatty acids in blood cells
- Registration Number
- NL-OMON33112
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PBMC gene expression profiles</p><br>
- Secondary Outcome Measures
Name Time Method <p>PBMC inflammatory response capacity<br /><br>Endothelial function<br /><br><br /><br>Tertiar:<br /><br>lipid profiles<br /><br>plasma glucose and insulin<br /><br>monocyte and lymfocyte gene expression profiles</p><br>