Alcohol & Metabolic Comorbidities in PLWHA: Evidence Driven Interventions

NCT03299205 | Completed

• 1 other identifier: 9767
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; Dysglycemia; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose and OGTT values (subclinical dysglycemia)

  Risk for subclinical dysglycemia

  Baseline

Secondary Outcomes (3)

• Skeletal muscle phenotype

  Baseline

• Fasting plasma glucose

  Change from baseline in fasting plasma glucose after 10 weeks

• myomiRs

  Change from baseline in myomiRs after 10 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Aerobic exercise program using treadmill.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

The exercise intervention consists of moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. Aerobic exercise will be conducted over 10-weeks in PLWHA +/- AUD. The programs 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 and progress to higher intensity exercise after week 4 of the program. All exercise will be completed on a treadmill and supervised by study staff. Each participant will be provided with a Fitbit Zip to monitor daily activity and steps with a goal of 7000 steps per day.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy
• 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)

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• Primeaux SD, Simon L, Ferguson TF, Levitt DE, Brashear MM, Yeh A, Molina PE. Alcohol use and dysglycemia among people living with human immunodeficiency virus (HIV) in the Alcohol & Metabolic Comorbidities in PLWH: Evidence Driven Interventions (ALIVE-Ex) study. Alcohol Clin Exp Res. 2021 Sep;45(9):1735-1746. doi: 10.1111/acer.14667. Epub 2021 Aug 2.

  PMID: 34342022 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcoholism

Interventions

Exercise

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Patricia Molina, MD, PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head Department of Physiology

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: November 20, 2017
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)