Cognition Metabolism and Exercise Among Women Living With HIV in Puerto Rico

HIV Clinical Trial

— CMEx  

Official title:

Soluble Insulin Receptor Dysfunction Correlates With HAND in HIV+ Women on CART

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962622
• Other study ID #: UPuertoRico
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2016
• Last updated: November 9, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: University of Puerto Rico
• Contact: Farah A. Ramirez-Marrero, PhD
• Phone: 787-602-0088
• Email: farah.ramirez1[@]upr.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study evaluates the association between soluble insulin receptor dysfunction, cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who volunteer to participate in the study will have two evaluations at study entry that include a dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing, blood and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA will be conducted in the Endocrinology Unit at the University Hospital, Medical Center (letter of support included). The cardiorespiratory fitness testing will be conducted in the AIDS Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences Campus, and the Puerto Rico Clinical and Translational Research Consortium. Then, participants will be invited to participate in a 6-week, 3 days/week individualized exercise program. The exercise program will be conducted at the University of Puerto Rico Medical Sciences Campus. After completion of the exercise program, study entry evaluations will be repeated. The duration of the study will take approximately 10 weeks.

Description:

The aim of the study is to determine the effect of a low volume high intensity interval training (HIIT) exercise intervention on cardio-respiratory fitness (CR-fitness), insulin resistance, and cognitive function among normally active but physically untrained HIV+ Hispanic women. The primary hypotheses are that HIIT will improve: 1) CR-fitness in all groups (HIV+ and HIV-), 2) insulin sensitivity in both groups of HIV+ women, and 3) cognitive function as determined by hippocampal function in HIV+ women with HAND. Participants will receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. Then, participants will be evaluated with a CR-fitness, insulin resistance, anthropometry, and neurocognitive function tests.

Participants will undergo an intervention (described above) designed for normally active but physically untrained HIV+ Hispanic women, one with (n=15) and other without (n=15) neurocognitive impairment & HIV- controls (n=15). After the HIIT intervention, measurements of CR-fitness, insulin resistance, and cognitive function including hippocampal function using the memory island test will be obtained, as well as CR-fitness, anthropometry, DEXA densitometry, and blood and urine samples for metabolic testing. The ultimate goal is to improve the understanding of mechanisms by which exercise influence neurocognitive function; thus, providing a potential non-pharmacological alternative to prevent, control or reduce chronic incapacitating diseases in HIV+ Hispanic adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. HIV-seropositive women =21 years with lymphocytes differentiated cells 4 (CD4) cell count or nadir in the last year =500 cells/mm3, or viral load =1,000 copies/mL despite highly active antiretroviral therapy (HAART).

2. Education level =9th grade, since is the minimum required for some of the neuro-psychological (NP) tests. All HIV-seropositive and HIV-seronegative participants will be tested for vocabulary and reading pre-morbid cognitive function as described below.

3. Non-drug abusers; defined as those with <5 exposures in a lifetime to drugs (opiates/heroin, methamphetamine, cocaine/crack, speed ball). For the purpose of this study neither tobacco nor nicotine use will be considered a drug.

4. No diagnosis of diabetes or the use of hypoglycemic agents.

Exclusion Criteria:

1. HIV+ women and men <21 years old with CD4 cell count >500 cells/mm3 and/or viral load <1,000 copies/mL.

2. Opportunistic infections of the central nervous system (CNS) as determined by neurological evaluation and neuroimaging. (Neuroimaging studies, if needed, will be performed as part of patient care and hence have not been included as a budget item in this proposal.)

3. History of diabetes or the use hypoglycemic agents.

4. Underlying neurologic and/or neuropsychiatric disorders such as cerebrovascular events; history of meningitis/encephalitis, CNS opportunistic infections, or seizures; head trauma (<6 months with loss of consciousness for >1 hr); cerebral palsy; or any other neuropsychiatric condition that in the judgment of the investigators may affect the study.

5. Active systemic infection or illness, which in the judgment of the investigators may affect the study.

6. Pregnant/nursing mothers or women with recent birth (<60 days).

7. Substance abuse: active drug use - all participants will be screened with urine toxicology and active alcohol abuse - those scoring >3 points in the Michigan Alcoholism Screening Test (MAST) will be screened with blood samples for alcohol levels (Seltzer 1975).

8. Patients who are unwilling to give informed consent or incapable of understanding informed consent.

9. Education less than 9th grade.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• High intensity interval training (HIIT)
Six weeks, three days per week (total of 18 sessions) of HIIT cycle ergometer exercise protocol

Locations

Country	Name	City	State
Puerto Rico	Medical Sciences Campus	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardio-respiratory fitness as measured by maximal oxygen consumption (VO2max)	Maximal oxygen consumption	6 weeks	No
Secondary	Metabolic syndrome classification based on the National Cholesterol Education Program (NCEP) criteria	Number of participants with abnormal values in 3 or more of the following: fasting glucose, resting blood pressure, waist circumference, fasting triglycerides, and HDL.	6 weeks	No
Secondary	Neurocognitive function as measured by memory testing	Number of participants with abnormal values of neurocognitive function will be identified. Measures of memory testing using questionnaires and a computer-based assessment will be aggregated to arrive at one reported value of neurocognitive function.	6 weeks	No