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Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03561571
Acronym
COMPLETE
Enrollment
32
Registered
2018-06-19
Start date
2018-10-15
Completion date
2019-05-14
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase

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

Interventions

OTHERbutter based breakfast

ingestion of proteins : 5 g, lipids 20 g, glucides 57 g

OTHERChocolate spread based breakfast

ingestion of proteins 7 g, lipids 20 g, glucides 56 g

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
fasting thromboxane B2 concentrationHour 0ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
after breakfast thromboxane B2 concentration4 hoursex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets

Secondary

MeasureTime frameDescription
measurement of fasting platelet activation by turbidimetric methodHour 0
measurement of post prandial platelet activation by turbidimetric method4 Hours
fasting lipidomic composition of triglyceride rich lipoproteinsHour 0Characterization 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 lipoproteins4 HoursCharacterization 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026