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Search / Trial NCT07027033

Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity

Launched by NANTES UNIVERSITY HOSPITAL · Jun 10, 2025

Trial Information

Current as of November 05, 2025

Not yet recruiting

Keywords

Obesity Visceral Adipose Tissue Adipocyte Dysfunction Oleic Acid Cholesterol Esterification

ClinConnect Summary

This clinical trial is studying whether adding a type of healthy fat called oleic acid to the diet can help improve how fat tissue works in women with obesity. Fat tissue, especially the kind around organs and under the skin, can become inflamed and cause problems like diabetes and heart disease in people with obesity. Researchers want to see if eating more oleic acid before weight-loss surgery (bariatric surgery) can protect this fat tissue and reduce these health risks.

The study is looking for women between 18 and 60 years old who have obesity severe enough to qualify for bariatric surgery and meet certain health criteria related to insulin resistance (a condition that can lead to diabetes). Participants must be of European descent and planning to have surgery at Nantes University Hospital. If you join, you’ll follow a special diet enriched either with regular oil or oil high in oleic acid before your surgery. During the surgery, small samples of fat tissue will be taken to study the effects. This research is still not recruiting participants but aims to better understand how diet can support healthier fat tissue in obesity.

Gender

FEMALE

Eligibility criteria

  • Inclusion 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).
  • Exclusion Criteria:
  • • 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-interventional studies and research on surgical techniques or postoperative strategies.
  • Type I, monogenic or secondary diabetes.

About Nantes University Hospital

Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.

Locations

Nantes, France

Patients applied

0 patients applied

Trial Officials

Marie De Montrichard, PH

Principal Investigator

Nantes University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported