Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
COMPLETE
Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
1 other identifier
interventional
32
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2019
CompletedAugust 22, 2025
August 1, 2019
7 months
May 25, 2018
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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
Study Arms (2)
Butter based breakfast
ACTIVE COMPARATORChocolate spread based breakfast
ACTIVE COMPARATORInterventions
ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
ingestion of proteins 7 g, lipids 20 g, glucides 56 g
Eligibility Criteria
You may qualify if:
- Menopausal women
- HbA1c ≥6,5 ou ≤10%
- ≤ BMI ≤40 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Louis Pradel - department of endocrinology
Bron, 69500, France
Related Publications (1)
Boulet MM, Cheillan D, Di Filippo M, Lelekov-Boissard T, Buisson C, Lambert-Porcheron S, Nazare JA, Tressou J, Michalski MC, Calzada C, Moulin P. Postprandial Triglyceride-Rich Lipoproteins from Type 2 Diabetic Women Stimulate Platelet Activation Regardless of the Fat Source in the Meal. Mol Nutr Food Res. 2020 Oct;64(19):e2000694. doi: 10.1002/mnfr.202000694. Epub 2020 Sep 9.
PMID: 32844550RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 19, 2018
Study Start
October 15, 2018
Primary Completion
May 14, 2019
Study Completion
May 14, 2019
Last Updated
August 22, 2025
Record last verified: 2019-08