Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT07027033

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

Led by Nantes University Hospital · Updated on 2026-01-15

40

Participants Needed

1

Research Sites

154 weeks

Total Duration

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AI-Summary

What this Trial Is About

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. Experimental data, obtained in preclinical models, suggest that the beneficial effects of oleic acid may protect the TAB by increasing cholesterol esterification. The NAMICO study aims to test this hypothesis using TAB biopsies collected from obese patients undergoing bariatric surgery who had previously undergone dietary enrichment with either a conventional oil or an oil rich in oleic acid.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Individual who has given informed consent.
  • Female adult aged between 18 and 60 years.
  • Patient with obesity at inclusion, meeting the HAS criteria for bariatric surgery eligibility: BMI 65 35 kg/m8 associated with a comorbidity or BMI > 40 kg/m8.
  • European origin: both parents identified by the patient as of European origin.
  • Effective contraception if sexually active, or abstinence, or menopause.
  • Presenting at inclusion with at least two clinical criteria of insulin resistance according to the International Diabetes Federation (IDF): dysglycemia (fasting glucose 65 100 mg/dL, glucose intolerance, or type 2 diabetes), hypertension (65 130/85 mm Hg), low HDL-cholesterol (< 50 mg/dL), elevated triglycerides (65 150 mg/dL).
  • Affiliated with a social security system or beneficiary of such a system.
  • Bariatric surgery performed at Nantes University Hospital (CHU de Nantes).
Not Eligible

You will not qualify if you...

  • 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 other substances 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 where inclusion may harm the patient's health or compromise the study.
  • Participation in other clinical trials except non-interventional studies and research on surgical techniques or postoperative strategies.
  • Type I, monogenic or secondary diabetes.

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Nantes

Nantes, France, France, 44093

Actively Recruiting

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Research Team

M

Marie De Montrichard, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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