ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measure of fibrotest to assess the liver fibrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection,
- •Aged to 18 at 65 ans,
- •Obesity defined as a Body Mass Index (BMI)> 35 kg / M² with comorbidities Or BMI > 40 kg/M²
- •Forget bariatric surgery after a positive opinion of the specialized multidisciplinary meeting
- •on stable antiretroviral therapy for 12 months
- •with controlled HIV infection (<50 copies / ml)
- •Signed informed consent
- •Karnofsky Index > 80 %
- •Patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
排除标准
- •Uncontrolled severe infection
- •Current pregnancy (positive HCG)
- •Saving justice, guardianship
- •Participation to another study.
结局指标
主要结局
Measure of fibrotest to assess the liver fibrosis
时间窗: 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.
Measure of viral load in plasma and adipose tissue assessed by quantification using Cobas 6800 system/cobas HIV-1 Test (Roche)
时间窗: 30 months
Measure of steatotest to assess the liver steatosis
时间窗: 30 months
Measure of the pharmacokinetics of antiretrovirals by estimating trough plasma concentrations using mass spectrometry assay.
时间窗: 30 months
Measure of actitest to assess the liver inflammation
时间窗: 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.
Measure of serum inflammatory biomarkers assessed by ELISA assay
时间窗: 30 months
Measure of the pharmacokinetics of antiretrovirals by estimating trough adipose tissue concentrations using mass spectrometry assay.
时间窗: 30 months
次要结局
- Measure of bone mineral density assessed by dexascan to evaluate the impact of sleeve gastrectomy(30 months)
- Measure of body composition assessed by dexascan to evaluate the impact of sleeve gastrectomy(30 months)
- Measure of Volume of epicardial fat assessed by echocardiography to evaluate cardiovascular function(30 months)
- Carotid intima media thickness assessed by echo-doppler to evaluate cardiovascular atherosclerosis(30 months)
- Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis(30 months)
- Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function(30 months)
- Measure of the surface of the adipose tissue subcutaneous and visceral assessed by tomodensitometry to evaluate the impact of sleeve gastrectomy(30 months)