Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Other: butter based breakfast; Other: Chocolate spread based breakfast

• Registration Number: NCT03561571
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Study Start: 2018-10-15
• Primary Completion: 2019-05-14
• Study Completion: 2019-05-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Menopausal women
• HbA1c ≥6,5 ou ≤10%
• 27 ≤ BMI ≤40 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butter based breakfast	butter based breakfast	-
Chocolate spread based breakfast	Chocolate spread based breakfast	-

Primary Outcome Measures

Name	Time	Method
fasting thromboxane B2 concentration	Hour 0	ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
after breakfast thromboxane B2 concentration	4 hours	ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets

Secondary Outcome Measures

Name	Time	Method
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	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	4 Hours	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).

Trial Locations

Locations (1)

Hôpital Louis Pradel - department of endocrinology; 🇫🇷 Bron, France