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Clinical Trials/NCT03561571
NCT03561571CompletedNot Applicable

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

Hospices Civils de Lyon2 sites in 1 country32 target enrollmentStarted: October 15, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
fasting thromboxane B2 concentration
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Active Comparator

Intervention: butter based breakfast (Other)

Chocolate spread based breakfast

Active Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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