Back to resultsTriglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes (COMPLETE)
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
butter based breakfast
Chocolate spread based breakfast
Sponsored by
About this trial
This is an interventional basic science trial for Type2 Diabetes focused on measuring chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase
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
Sites / Locations
- Hôpital Louis Pradel - department of endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Butter based breakfast
Chocolate spread based breakfast
Arm Description
Outcomes
Primary Outcome Measures
fasting thromboxane B2 concentration
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
after breakfast thromboxane B2 concentration
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Secondary Outcome Measures
measurement of fasting platelet activation by turbidimetric method
measurement of post prandial platelet activation by turbidimetric method
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03561571
Brief Title
Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
Acronym
COMPLETE
Official Title
Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butter based breakfast
Arm Type
Active Comparator
Arm Title
Chocolate spread based breakfast
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
butter based breakfast
Intervention Description
ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
Intervention Type
Other
Intervention Name(s)
Chocolate spread based breakfast
Intervention Description
ingestion of proteins 7 g, lipids 20 g, glucides 56 g
Primary Outcome Measure Information:
Title
fasting thromboxane B2 concentration
Description
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Time Frame
Hour 0
Title
after breakfast thromboxane B2 concentration
Description
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
measurement of fasting platelet activation by turbidimetric method
Time Frame
Hour 0
Title
measurement of post prandial platelet activation by turbidimetric method
Time Frame
4 Hours
Title
fasting lipidomic composition of triglyceride rich lipoproteins
Description
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).
Time Frame
Hour 0
Title
post prandial lipidomic composition of triglyceride rich lipoproteins
Description
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).
Time Frame
4 Hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpital Louis Pradel - department of endocrinology
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
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