The Visceral Adiposity Measurement and Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 5
- 主要终点
- Visceral Adiposity Measurement by CT surface area (cm2).
研究概览
简要总结
The Visceral Adiposity Measurement and Observation Study
详细描述
Visceral adiposity (VA) is a form of ectopic fat deposition that correlates with cardiometabolic risk in both the general population and among people with human immunodeficiency virus (HIV) (PWH).1 Excess VA (EVA) is prevalent among PWH,2,3 and prevalence rises with age and time on antiretroviral treatment.3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities, possibly due to adverse metabolic effects of certain antiretroviral agents, the low-level expression of HIV gene products within the adipose tissue, and other factos.4
Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy (ART),2,3 it may go unrecognized or be mischaracterized as generalized obesity. Whereas obesity and EVA both increase waist circumference (WC), they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots, whereas individuals with EVA accumulate fat within the abdominal cavity. Ectopic fat accumulation (EFA) also occurs at various other depots, namely around and within various internal organs (e.g., the heart, skeletal muscle, liver, and pancreas).1,5 For purposes of the VAMOS study, EFA is defined as the amount of pericardial fat, skeletal muscle fat, and liver fat the VAMOS study subjects have. VA for the VAMOS study is held separately as it is the primary endpoint.
Because it represents a potentially modifiable cardiovascular risk factor among PWH, simple, practical surrogate markers are needed to identify patients with probable EVA. Anthropometric measurements such as WC correlate with EVA in the general population1, but their predictive value is less well defined for subgroups of PWH.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, ≥18 years
- •HIV+, on continuous ART for ≥12 months
- •≥3 years since initiation of ART
- •20.0 ≤ BMI ≤ 40.0 kg/m2
排除标准
- •Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) > 1000/mL
- •Unable or unwilling to undergo any study procedures
- •Known hepatic cirrhosis
- •Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA
- •Hepatitis B positive
- •Current pregnancy or breastfeeding
- •History of liver transplant
- •Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake)
- •Any active malignancy, excluding non-melanoma skin cancer
- •Patient has been treated with tesamorelin or human growth hormone within the last 12 months
- •Patient has used insulin in the previous year
- •Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program
研究组 & 干预措施
Study Participants
Waist and hip circumferences, CT Scan and FibroScan and Quality of Life questionnaire, vital signs, urine and blood testing in Adults with HIV on continuous Anti-Retroviral Therapy treatment.
干预措施: Diagnostic Test (Diagnostic Test)
Study Participants
Waist and hip circumferences, CT Scan and FibroScan and Quality of Life questionnaire, vital signs, urine and blood testing in Adults with HIV on continuous Anti-Retroviral Therapy treatment.
干预措施: HIV Anti-retroviral Background Therapy (Drug)
结局指标
主要结局
Visceral Adiposity Measurement by CT surface area (cm2).
时间窗: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Umbilical waist circumference measurement (in cm).
时间窗: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Iliac waist circumference measurement (in cm).
时间窗: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
次要结局
- Visceral Adiposity Measurement by CT surface area (cm2)(Baseline)
- Visceral Adiposity Measurement by CT volume (cm3).(Baseline)
- Health related quality of life evaluation by SF-36 questionnaire(Baseline)
- Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute(Baseline)
- Framingham Cardiovascular Risk strata (low, intermediate or high)(Baseline)
- Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).(Baseline)
- Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.(Baseline)
- Health related quality of life evaluation by VAMOS disease specific questionnaire(Baseline)
- Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa(Baseline)