Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

NCT ID: NCT03561571

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-05-14

Brief Summary

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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

Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Butter based breakfast

Group Type ACTIVE_COMPARATOR

butter based breakfast

Intervention Type OTHER

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

Chocolate spread based breakfast

Group Type ACTIVE_COMPARATOR

Chocolate spread based breakfast

Intervention Type OTHER

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

Interventions

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butter based breakfast

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

Intervention Type OTHER

Chocolate spread based breakfast

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Louis Pradel - department of endocrinology

Bron, , France

Site Status

Countries

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France

References

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Boulet MM, Cheillan D, Di Filippo M, Lelekov-Boissard T, Buisson C, Lambert-Porcheron S, Nazare JA, Tressou J, Michalski MC, Calzada C, Moulin P. Postprandial Triglyceride-Rich Lipoproteins from Type 2 Diabetic Women Stimulate Platelet Activation Regardless of the Fat Source in the Meal. Mol Nutr Food Res. 2020 Oct;64(19):e2000694. doi: 10.1002/mnfr.202000694. Epub 2020 Sep 9.

Reference Type RESULT
PMID: 32844550 (View on PubMed)

Other Identifiers

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69HCL18_0326

Identifier Type: -

Identifier Source: org_study_id

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