HIV (Human Immunodeficiency Virus)NCT00857298
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
A study testing Dietary Intervention in people with HIV (Human Immunodeficiency Virus) and Metabolic Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Metabolic Syndrome, HIV Infections
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2014
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary
- Obese
- Have either dyslipidemia (HDL < 50 or triglycerides > 150), waist circumference > 88cm, and impaired glucose tolerance or homeostasis model assessment value of > 3
- Subjects with HIV-MS must have been receiving HAART for > 6 months
Who cannot join
- Medication changes in the last 3 months
- Diabetes mellitus
- Medical problems that in the opinion of the principal investigator may interfere with patient safety
- Substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.
- Being tested
- Dietary Intervention
- Keywords
- HIV, Metabolic Syndrome, Obesity, Treatment Experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Metabolic Syndrome, HIV Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
The nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be ~750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets.
| Study group | Role | What they receive |
|---|---|---|
| HIV-MS | Active comparator | HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight Receives: Behavioral: Dietary Intervention |
| MS only | Active comparator | HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of weight loss on body composition
Measured: three months
Effect of weight loss on insulin action
Measured: three months
Secondary outcomes (6)
Effect of weight loss on body fat mass
Measured: three months
Effect of weight loss on adipose tissue distribution
Measured: three months
Effect of weight loss intrahepatic triglyceride content
Measured: three months
Effect of weight loss on insulin action adipose tissue
Measured: three months
Effect of weight loss on insulin action in liver
Measured: three months
Effect of weight loss on insulin action in skeletal muscle
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2014
- Study completionJul 2014
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 (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Reeds, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857298
- Sponsor's protocol ID
- HW-08-0628
- Status last verified
- Feb 2015
- First submitted
- 4 Mar 2009
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reeds DN, Pietka TA, Yarasheski KE, Cade WT, Patterson BW, Okunade A, Abumrad NA, Klein S. HIV infection does not prevent the metabolic benefits of diet-induced weight loss in women with obesity. Obesity (Silver Spring). 2017 Apr;25(4):682-688. doi: 10.1002/oby.21793. Epub 2017 Feb 28.
PubMed 28245099
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00857298
- Acronym / sponsor ID
- HW-08-0628
- Keywords
- HIV, Metabolic Syndrome, Obesity, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Mar 2009 (estimated)
- 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.
Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-MS | Active comparator | Behavioral: Dietary InterventionHIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight |
| MS only | Active comparator | Behavioral: Dietary InterventionHIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sedentary
- Obese
- Have either dyslipidemia (HDL < 50 or triglycerides > 150), waist circumference > 88cm, and impaired glucose tolerance or homeostasis model assessment value of > 3
- Subjects with HIV-MS must have been receiving HAART for > 6 months
Key exclusion criteria (4 listed)
- Medication changes in the last 3 months
- Diabetes mellitus
- Medical problems that in the opinion of the principal investigator may interfere with patient safety
- Substance abuse
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 |
|---|---|---|
| Dietary InterventionThe nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be ~750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets. | Behavioural | HIV-MS, MS only |
Primary outcome
Effect of weight loss on body composition
Time frame: three months
Effect of weight loss on insulin action
Time frame: three months
6 secondary outcomes
Effect of weight loss on body fat mass
Time frame: three months
Effect of weight loss on adipose tissue distribution
Time frame: three months
Effect of weight loss intrahepatic triglyceride content
Time frame: three months
Effect of weight loss on insulin action adipose tissue
Time frame: three months
Effect of weight loss on insulin action in liver
Time frame: three months
Effect of weight loss on insulin action in skeletal muscle
Time frame: three months
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 16 Feb 2015.
- Derived from this study: PubMed 28245099Reeds DN, Pietka TA, Yarasheski KE, Cade WT, Patterson BW, Okunade A, Abumrad NA, Klein S. HIV infection does not prevent the metabolic benefits of diet-induced weight loss in women with obesity. Obesity (Silver Spring). 2017 Apr;25(4):682-688. doi: 10.1002/oby.21793. Epub 2017 Feb 28.
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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.
Dominic Reeds, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with HIV (Human Immunodeficiency Virus) and Metabolic Syndrome, run by Washington University School of Medicine 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 4 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 16 Feb 2015. 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?
Effect of weight loss on body composition (time frame: three months). The study lists 2 primary outcomes in all. 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 NCT00857298, 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 16 Feb 2015.