Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- fasting thromboxane B2 concentration
Study Overview
Brief Summary
To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type 2 diabetic women in the fasting state and following a randomized isocaloric lipid rich breakfast on control human platelets
Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Menopausal women
- •HbA1c ≥6,5 ou ≤10%
- •27 ≤ BMI ≤40 kg/m2
Exclusion Criteria
- •Insulin therapy
- •fibrates or Omega 3 fatty acids supplements
- •Hormonal replacement therapy of menopause
- •Glycemia > 16 mmol/l
- •Alcohol abuse (≥3 Unit/day)
- •Special dietary habits
- •History of bariatric surgery
Arms & Interventions
Butter based breakfast
Intervention: butter based breakfast (Other)
Chocolate spread based breakfast
Intervention: Chocolate spread based breakfast (Other)
Outcomes
Primary Outcomes
fasting thromboxane B2 concentration
Time Frame: Hour 0
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
after breakfast thromboxane B2 concentration
Time Frame: 4 hours
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Secondary Outcomes
- measurement of fasting platelet activation by turbidimetric method(Hour 0)
- measurement of post prandial platelet activation by turbidimetric method(4 Hours)
- fasting lipidomic composition of triglyceride rich lipoproteins(Hour 0)
- post prandial lipidomic composition of triglyceride rich lipoproteins(4 Hours)
