Obesity, Subcutaneous Adipose Tissue, Visceral Adipose Tissue, White Adipose Tissue Inflammation
Conditions
Keywords
obesity, visceral adipose tissue, adipocyte dysfunction, oleic acid, cholesterol esterification
Brief summary
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.
Interventions
OTHERacid-rich sunflower oil oleic acid
Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of sunflower oil rich in oleic acid
OTHERconventional sunflower oil
Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of conventional sunflower oil
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Oil bottles will be numbered in accordance with a correspondence list generated electronically by the datamanager (blinding procedure for participant, investigator and their team).
Intervention model description
NAMICO is a physio-pathologic, monocentric, controlled , blinded, randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of consuming oleic acid-rich sunflower oil versus conventional sunflower oil on cholesterol esterification within visceral white adipose tissue. | 13 weeks +/- 2 week | The primary endpoint of the study is to compare the cholesterol esterification rates in adipocytes between the two experimental groups. This is measured by the ratio of esterified cholesterol (EC) to free cholesterol (FC), expressed as a percentage, determined from samples of visceral adipose tissue collected perioperatively after 13 weeks (± 2 week) of the nutritional supplementation under investigation. |
Countries
France
Contacts
Primary ContactMarie De Montrichard, PH
Outcome results
None listed