Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes (COMPLETE)

Civil Hospices of Lyon

Status: Completed

Conditions: Type2 Diabetes

Treatments: Other: Chocolate spread based breakfast; Other: butter based breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT03561571

69HCL18_0326

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Butter based breakfast

Active Comparator group

Treatment:

Other: butter based breakfast

Chocolate spread based breakfast

Active Comparator group

Treatment:

Other: Chocolate spread based breakfast