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New treatment option for Obesity
Official title Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity
ClinicalTrials.gov ID: NCT07027033
What this study is testing
- What it's testing
- Disruption of white adipose tissue (WAT) homeostasis during obesity is central to the development of associated cardiometabolic complications. Dietary supplementation with oleic acid in obese patients can limit these complications.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Individual who has given informed consent.
- Female adult aged between 18 and 60 years (included).
- Patient with obesity at inclusion, meeting the HAS criteria for bariatric surgery eligibility: BMI ≥ 35 kg/m² associated with a comorbidity or BMI \>...
- European origin: For this pilot study, we need to reduce variability factors and focus the research on women of European descent only (having both...
- Effective contraception if sexually active, or abstinence, or menopause (criterion required for bariatric surgery).
You likely can't join if
- Modification of diabetes treatment within the past month.
- Ongoing or planned insulin therapy before bariatric surgery.
- Modification of lipid-lowering treatment within the past three months.
- Systemic corticosteroid therapy.
- Antiviral therapy (HIV).
- Dietary supplementation affecting lipid metabolism, including proactive margarine, Danacol, polyunsaturated fatty acid supplementation, or any other...
See the full eligibility criteria
- Individual who has given informed consent.
- Female adult aged between 18 and 60 years (included).
- Patient with obesity at inclusion, meeting the HAS criteria for bariatric surgery eligibility: BMI ≥ 35 kg/m² associated with a comorbidity or BMI \> 40 kg/m².
- European origin: For this pilot study, we need to reduce variability factors and focus the research on women of European descent only (having both parents identified by the patient as of European origin).
- Effective contraception if sexually active, or abstinence, or menopause (criterion required for bariatric surgery).
- Presenting at inclusion with at least two clinical criteria of insulin resistance according to the definition of the International Diabetes Federation (IDF):
- Dysglycemia (fasting glucose ≥ 100 mg/dL, glucose intolerance, or type 2 diabetes).
- Hypertension (≥ 130/85 mm Hg).
- Low HDL-cholesterol (\< 50 mg/dL).
- Elevated triglycerides (≥ 150 mg/dL).
- Affiliated with a social security system or a beneficiary of such a system.
- Bariatric surgery performed at Nantes University Hospital (CHU de Nantes).
- Modification of diabetes treatment within the past month.
- Ongoing or planned insulin therapy before bariatric surgery.
- Modification of lipid-lowering treatment within the past three months.
- Systemic corticosteroid therapy.
- Antiviral therapy (HIV).
- Dietary supplementation affecting lipid metabolism, including proactive margarine, Danacol, polyunsaturated fatty acid supplementation, or any other substance identified by the investigator.
- Exocrine pancreatic insufficiency.
- Pregnancy or breastfeeding.
- History of organ transplantation.
- Individual deprived of liberty or under legal protection (guardianship or trusteeship).
- Any clinical condition in which the investigator considers that inclusion in the study may harm the patient's health or compromise the proper conduct of the study.
- Participation in other clinical trials, except for non-treatment studies and research on surgical techniques or postoperative strategies.
- Type I, monogenic or secondary diabetes.
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.