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OpenTrials
Completed

NCT Number: NCT03561571

Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

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

Completed

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Pradel - department of endocrinology

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

butter based breakfast

Other

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

Chocolate spread based breakfast

Other

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

Primary outcomes

  1. fasting thromboxane B2 concentration

    Time frame: Hour 0

    ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets

  2. 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

  1. measurement of fasting platelet activation by turbidimetric method

    Time frame: Hour 0

  2. measurement of post prandial platelet activation by turbidimetric method

    Time frame: 4 Hours

  3. fasting lipidomic composition of triglyceride rich lipoproteins

    Time frame: 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).

  4. post prandial lipidomic composition of triglyceride rich lipoproteins

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COMPLETE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2018
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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