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临床试验/NCT03299205
NCT03299205已完成不适用

Alcohol & Metabolic Comorbidities in PLWHA: Evidence Driven Interventions

Louisiana State University Health Sciences Center in New Orleans2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Fasting plasma glucose and OGTT values (subclinical dysglycemia)

研究概览

简要总结

Cross-sectional and prospective studies are proposed to test the prediction that a higher proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise intervention in improving glycemic control. Results will inform larger scale interventions to ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease hazardous alcohol drinking.

详细描述

Adult male and female in care PLWHA with fasting plasma glucose (FPG) >94 mg/dL and <125 mg/dL will be recruited. Measures of FPG and HbA1c obtained from overnight fasted subjects. Alcohol use disorder (AUD) will be assessed by AUDIT and time-line follow back questionnaires, coupled with Phosphatidylethanol (PEth) measures. Glucose tolerance will be assessed by oral glucose tolerance test (OGTT). Blood sample collected at the time of the OGTT will be used for determination of circulating levels of adipokines (adiponectin and resistin).

A subset of adult male and female PLWHA +/- AUD with impaired OGTT will be recruited to undergo skeletal muscle (SKM) biopsy (vastus lateralis), 90 min after a defined (calorie and nutrient composition) meal (i.e.,Ensure, Carnation Instant Breakfast). Muscle samples will be used for phenotype characterization (markers of inflammation, insulin signaling, mitochondrial homeostasis) and for myoblast isolation.

Adult male and female PLWHA +/- AUD with impaired OGTT will undergo a moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. A SKM biopsy will be performed after completion of the exercise protocol in a subset of subjects to examine the changes in gene expression and myoblast mitochondrial oxidative capacity. We will expand recruitment by enrolling PLWHA +/- AUD based on a FPG between 94-120 mg/dL to participate in the exercise intervention. Clearance for participation in this study will require EKG, completion of a physical activity readiness questionnaire, and medical clearance from a staff clinician. Individuals with significant peripheral neuropathies or the prevalence of significant cardiovascular impairments (i.e. resting cardiac abnormalities or arrhythmias, severe hypertension, etc.) will be excluded from exercise testing or intervention. The 10-week exercise intervention program will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity (40 to 50% of heart rate reserve; HRR) and progress to a higher intensity (50 to 60% HRR) exercise after week 4 of the program. The frequency and duration of exercise sessions will remain constant after week 4 so the absolute dose of exercise will be altered through increasing intensity, i.e. from low-moderate to more vigorous. All exercise will be completed on a treadmill at the Louisiana State University Health Sciences Center (LSUHSC) Wellness Center. Additionally, each participant will be provided with a Fitbit Zip to monitor daily activity and steps. Data from the Fitbit Zip will be downloaded weekly basis. Participants will be given a healthy step goal of 7000 steps per day. Based on initial step counts after the first week of wearing the accelerometer, individual goals will be discussed with the participants. Personal limitations that develop during the study period (i.e. peripheral neuropathy, orthopedic limitation, etc.) will be monitored and will be reason for exclusion from the exercise program. All sessions will be supervised and adherence to the exercise prescription will be fully monitored under the supervision and care of Dr. Stefany Primeaux in consultation with Dr. Neil Johannsen.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV positive
  • Fasting glucose above 94 mg/dL and below 125 mg/dl
  • Without diagnosis of diabetes mellitus
  • "No" response to six questions in Physical Activity Readiness Questionnaire (PAR-Q), given at time of screening

排除标准

  • Lack of informed consent
  • Decisionally impaired individuals
  • Non-English speaking
  • Acute illness within the preceding six weeks (defined as fever, new antibiotic use or unscheduled healthcare visit (for illness))
  • Acute alcohol intoxication
  • Currently prescribed blood thinners (if undergoing muscle biopsy)
  • Allergy to Lidocaine (if undergoing muscle biopsy)
  • Significant peripheral neuropathies (if undergoing exercise)
  • Significant cardiovascular impairments (if undergoing exercise)

结局指标

主要结局

Fasting plasma glucose and OGTT values (subclinical dysglycemia)

时间窗: Baseline

Risk for subclinical dysglycemia

次要结局

  • myomiRs(Change from baseline in myomiRs after 10 weeks)
  • Skeletal muscle phenotype(Baseline)
  • Fasting plasma glucose(Change from baseline in fasting plasma glucose after 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Molina

Professor and Head Department of Physiology

Louisiana State University Health Sciences Center in New Orleans

研究点 (2)

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