Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02820337 |
| Other study ID # |
CREPATS 05 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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:
- morbid obesity (BMI ≥ 40 kg / M²) resistant to medical treatment and exposing patients
to serious complications that can not be controlled by the specific treatment
- obesity with BMI between 35 and 40 kg / M² with comorbidities associated with
life-threatening or functional outcomes: cardiovascular disease, musculoskeletal
disease, severe metabolic disorders not controlled by maximal medical therapy. In each
case, the indication can be considered in patients who have had access to specialized
medical care for at least 6 months, also including complementary approaches (diet,
physical activity, management of psychological problems, treatment complications).
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.
