Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

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

Official Title
-----------------
Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Other: butter based breakfast
* Other: Chocolate spread based breakfast


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Butter based breakfast<br> | Other: butter based breakfast<br>* ingestion of proteins : 5 g, lipids 20 g, glucides 57 g<br>|
| Active Comparator: Chocolate spread based breakfast<br> | Other: Chocolate spread based breakfast<br>* ingestion of proteins 7 g, lipids 20 g, glucides 56 g<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting thromboxane B2 concentration | ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets | Hour 0 | 
| after breakfast thromboxane B2 concentration | ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Characterization and comparison of LRT lipidomics in fasting DT2 patients and following the ingestion of a high-fat breakfast according to their source (short and medium chain fatty acids (butter) versus palmitic acid (palm oil present in spreads). | Hour 0 | 
| post prandial lipidomic composition of triglyceride rich lipoproteins | Characterization and comparison of LRT lipidomics in fasting DT2 patients and following the ingestion of a high-fat breakfast according to their source (short and medium chain fatty acids (butter) versus palmitic acid (palm oil present in spreads). | 4 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase