HIV/AIDSALIVE-ExNCT03299205
Alcohol & Metabolic Comorbidities in PLWHA: Evidence Driven Interventions
A study testing Exercise in people with HIV/AIDS and Dysglycemia, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Dysglycemia, Alcohol Use Disorder
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
About this study
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.
Read the detailed 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.
- Conditions
- HIV/AIDS, Dysglycemia, Alcohol Use Disorder
- Being tested
- Exercise
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Aerobic exercise program using treadmill. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose and OGTT values (subclinical dysglycemia)
Risk for subclinical dysglycemia
Measured: Baseline
Secondary outcomes (3)
Skeletal muscle phenotype
Subclinical dysglycemia associated with dysfunctional skeletal muscle measured by myomiRs
Measured: Baseline
Fasting plasma glucose
Glycemic control measured by fasting plasma glucose
Measured: Change from baseline in fasting plasma glucose after 10 weeks
myomiRs
Dysfunctional SKM measured by myomiRs
Measured: Change from baseline in myomiRs after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start20 Nov 2017
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Molina, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Patricia Molina, MD, PhD, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299205
- Sponsor's protocol ID
- 9767
- Acronym
- ALIVE-Ex
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for access to biological samples or existing clinical data obtained from our subjects will be evaluated by Dr. Molina.
Publications
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.
PubMed 34342022
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol & Metabolic Comorbidities in PLWHA: Evidence Driven Interventions
- ClinicalTrials.gov ID
- NCT03299205
- Acronym / sponsor ID
- ALIVE-Ex / 9767
- Conditions
- HIV/AIDS, Dysglycemia, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseAerobic exercise program using treadmill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise |
Primary outcome
Fasting plasma glucose and OGTT values (subclinical dysglycemia)
Time frame: Baseline
Risk for subclinical dysglycemia
3 secondary outcomes
Skeletal muscle phenotype
Time frame: Baseline
Fasting plasma glucose
Time frame: Change from baseline in fasting plasma glucose after 10 weeks
myomiRs
Time frame: Change from baseline in myomiRs after 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 34342022Primeaux 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.
- Individual participant dataSharing planned: No. Requests for access to biological samples or existing clinical data obtained from our subjects will be evaluated by Dr. Molina.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Molina, MD, PhD principal investigator
Louisiana State University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with HIV/AIDS and Dysglycemia, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose and OGTT values (subclinical dysglycemia) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.