Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

Type2 Diabetes Clinical Trial

— COMPLETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561571
• Other study ID #: 69HCL18_0326
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• butter based breakfast
ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
• Chocolate spread based breakfast
ingestion of proteins 7 g, lipids 20 g, glucides 56 g

Locations

Country	Name	City	State
France	Hôpital Louis Pradel - department of endocrinology	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting thromboxane B2 concentration	ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets	Hour 0
Primary	after breakfast thromboxane B2 concentration	ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets	4 hours
Secondary	measurement of fasting platelet activation by turbidimetric method		Hour 0
Secondary	measurement of post prandial platelet activation by turbidimetric method		4 Hours
Secondary	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).	Hour 0
Secondary	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).	4 Hours