Yasmine Dudoit
Paris, 75013, France
NCT Number: NCT02820337
The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV infection, anf morbid obesity with undetectable viral load (VL) and having HIV lipohypertrophy particularly truncal. The study covers both the morphology of adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue and the plasma before and after bariatric surgery.
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Notify Me18 year–65 year
All sexes
Observational
Paris, 75013, France
The choice of the sleeve gastrectomy is based on choosing an effective technique with few complications, no rupture of digestive continuity and therefore little malabsorptive effect with a better quality of life.
The intervention of sleeve gastrectomy offers a unique opportunity to study the SAT and VAT of HIV obese patients before and after bariatric surgery, to analyze the specific modifications of this tissue and to better understand the pathophysiology of this disease. The term associated with changes in cardiometabolic comorbidities and their improvement after weight loss will be important elements in the management of these patients. It is therefore important to evaluate whether the fibrosis term changes observed in HIV patients will change the effectiveness of the intervention.
In the general population, obesity is a major public health problem. It is considered an inflammatory disease, multifactorial with chronic evolution, which requires long-term medical care and / or surgery . Indeed, the body mass index (BMI) correlates with increased mortality mainly due to cardiovascular diseases (hypertension, coronary artery disease), cancer and diabetes. Finally, overweight and obesity are the leading causes of liver disease in Western countries resulting in nonalcoholic fatty liver disease, a term that includes all the hepatic lesions observed in overweight and obesity: steatosis, steatohepatitis, fibrosis, cirrhosis or hepatocellular carcinoma. Nonalcoholic fatty liver disease reflects not only the presence of insulin resistance but also participates in its installation. Reducing overweight is therefore a key part of treatment to reduce chronic inflammation, insulin resistance and liver damage.
There is little data in the literature on the prevalence of obesity in the population of HIV patients. In France, the prevalence of obesity in the French Hospital Database on HIV is 15.1% among women and 5.3% among men, similar to prevalence in the general population. Patients born in sub-Saharan Africa have a higher risk with 20.7% versus 12.2% in women and 10.9% versus 4.7% for men.
No data is available on the obesity complications described in the general population in our population of obese HIV patients. Nevertheless, apart from obesity, patients infected with HIV develop cardiovascular and metabolic complications well documented in recent years.
French and international recommendations agree that the management of obesity should be multidisciplinary. In the treatment, surgical treatment is the treatment of choice in French and international recommendations in the following indications:
At present, the sleeve gastrectomy is the technique of choice in the general population with, compared to other bariatric surgery techniques such as bypass, reducing complications, length of hospital stay, operative time, a gain in term quality of life without disruption of digestive continuity and therefore little or no malabsorption. This lack of malabsorption it an argument of choice in our HIV patients on cART with a reduced risk of malabsorption of ARV and vitamin deficiencies such as vitamin D deficiency already well described in HIV. The minimally invasive approach (1 trocar), routinely performed by Dr. G. Pourcher for obese patients whether they are infected with HIV, reduces surgical risk. This Single port also allows easy access to SAT, VAT and liver.
The management of obesity in the HIV population, now having a similar life expectancy should be the same as that of the general population but remains to this day very marginal. The literature on the subject is almost "poor" Additionally, comorbid conditions existing in the population of HIV patients are a target population requiring support at least equivalent to that of the general population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 months
fibrotest is the estimated index of liver fibrosis established according to the assay values of 5 parameters: alpha-2 macroglobulin, haptoglobin, apolipoprotein-A1, total bilirubin and g-glutamyl-transpeptidase.
Time frame: 30 months
ActiTest gives an estimate of the intensity of the inflammation and liver cell killing activity. ActiTest uses 5 markers fibrotest which is added the dosage of transaminases measure of Ambulatory blood pressure.
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Other
ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port
Acronym: ObéVIH
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