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

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ClinicalTrials.gov Identifier: NCT03561571
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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


Condition or disease Intervention/treatment Phase
Type2 Diabetes Other: butter based breakfast Other: Chocolate spread based breakfast Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Butter based breakfast Other: butter based breakfast
ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
Active Comparator: Chocolate spread based breakfast Other: Chocolate spread based breakfast
ingestion of proteins 7 g, lipids 20 g, glucides 56 g


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561571


Locations
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France
Hôpital Louis Pradel - department of endocrinology
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03561571    
Other Study ID Numbers: 69HCL18_0326
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
chylomicrons
Very Low Density Lipoprotein
saturated fat
 platelet function
type 2 diabetes
post prandial phase
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases