Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03299205
Study type Interventional
Source Louisiana State University Health Sciences Center in New Orleans
Contact
Status Completed
Phase N/A
Start date November 20, 2017
Completion date September 15, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04788004 - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting NCT05684094 - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function N/A
Completed NCT03406039 - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems N/A
Completed NCT03573167 - Mobile Phone-Based Motivational Interviewing in Kenya N/A
Completed NCT04817410 - ED Initiated Oral Naltrexone for AUD Phase 1
Active, not recruiting NCT04267692 - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders N/A
Completed NCT03872128 - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders Phase 1
Completed NCT02989662 - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers Phase 1/Phase 2
Recruiting NCT06030154 - Amplification of Positivity for Alcohol Use N/A
Active, not recruiting NCT05419128 - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19 N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04203966 - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting NCT05861843 - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Enrolling by invitation NCT04128761 - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder N/A
Not yet recruiting NCT06337721 - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Enrolling by invitation NCT02544581 - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare N/A