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

August 6, 2019 updated by: Hospices Civils de Lyon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Louis Pradel - department of endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of fasting platelet activation by turbidimetric method
Time Frame: Hour 0
Hour 0
measurement of post prandial platelet activation by turbidimetric method
Time Frame: 4 Hours
4 Hours
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).
Hour 0
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).
4 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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