Type2 DiabetesCOMPLETENCT03561571
Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
A study testing butter based breakfast and Chocolate spread based breakfast in people with Type2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- butter based breakfast and Chocolate spread based breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal women
- HbA1c ≥6,5 ou ≤10%
- 27 ≤ BMI ≤40 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Type2 Diabetes
- Being tested
- butter based breakfast, Chocolate spread based breakfast
- Keywords
- chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
butter based breakfastOther
ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
Chocolate spread based breakfastOther
ingestion of proteins 7 g, lipids 20 g, glucides 56 g
| Study group | Role | What they receive |
|---|---|---|
| Butter based breakfast | Active comparator | Not described Receives: Other: butter based breakfast |
| Chocolate spread based breakfast | Active comparator | Not described Receives: Other: Chocolate spread based breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting thromboxane B2 concentration
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Measured: Hour 0
after breakfast thromboxane B2 concentration
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
Measured: 4 hours
Secondary outcomes (4)
measurement of fasting platelet activation by turbidimetric method
Measured: Hour 0
measurement of post prandial platelet activation by turbidimetric method
Measured: 4 Hours
fasting lipidomic composition of triglyceride rich lipoproteins
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).
Measured: Hour 0
post prandial lipidomic composition of triglyceride rich lipoproteins
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).
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start15 Oct 2018
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561571
- Sponsor's protocol ID
- 69HCL18_0326
- Acronym
- COMPLETE
- Status last verified
- Aug 2019
- First submitted
- 25 May 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32844550
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
- ClinicalTrials.gov ID
- NCT03561571
- Acronym / sponsor ID
- COMPLETE / 69HCL18_0326
- Conditions
- Type2 Diabetes
- Keywords
- chylomicrons, Very Low Density Lipoprotein, saturated fat, platelet function, type 2 diabetes, post prandial phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butter based breakfast | Active comparator | Other: butter based breakfast |
| Chocolate spread based breakfast | Active comparator | Other: Chocolate spread based breakfast |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Menopausal women
- HbA1c ≥6,5 ou ≤10%
- 27 ≤ BMI ≤40 kg/m2
Key exclusion criteria (7 listed)
- Insulin therapy
- fibrates or Omega 3 fatty acids supplements
- Hormonal replacement therapy of menopause
- Glycemia > 16 mmol/l
- Alcohol abuse (≥3 Unit/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| butter based breakfastingestion of proteins : 5 g, lipids 20 g, glucides 57 g | Other | Butter based breakfast |
| Chocolate spread based breakfastingestion of proteins 7 g, lipids 20 g, glucides 56 g | Other | Chocolate spread based breakfast |
Primary outcome
fasting thromboxane B2 concentration
Time frame: Hour 0
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
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 secondary outcomes
measurement of fasting platelet activation by turbidimetric method
Time frame: Hour 0
measurement of post prandial platelet activation by turbidimetric method
Time frame: 4 Hours
fasting lipidomic composition of triglyceride rich lipoproteins
Time frame: Hour 0
post prandial lipidomic composition of triglyceride rich lipoproteins
Time frame: 4 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 32844550Boulet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing butter based breakfast and Chocolate spread based breakfast in people with Type2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting thromboxane B2 concentration (time frame: Hour 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.