LipodystrophyMETALIPNCT02614027
Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances
An observational study of Lipodystrophy and Metabolic Syndrome, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
Trial summary
To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy, Metabolic Syndrome
- What is being tested?
- Evaluation of metabolic syndrome and Evaluation of changes in fat by DXA while on current therapy
- Type of treatment
- Injection or infusion
- How many people
- 276 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Jun 2018
- Phase
- Observational
- 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
Study population: HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.
Who may be able to join
- HIV infection
- Older than 18 years
- Receiving first or second antiretroviral regimen or
- Previous evaluation and classification of lipodystrophy syndrome
Who cannot join
- Pregnancy
- Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids or hormones before inclusion
- Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients
To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.
Read the detailed description
Cross-sectional evaluation of two groups of patients:
- patients receiving currently available drugs, in order to determine the changes in fat accumulation by successive dual X-ray absorptiometry (DXA) determinations
- patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance (insulin resistance or diabetes), fat accumulation (waist circumference) and hypertriglyceridemia.
The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).
- Conditions
- Lipodystrophy, Metabolic Syndrome
- Being tested
- Evaluation of metabolic syndrome, Evaluation of changes in fat by DXA while on current therapy
- Medical subject headings
- Lipodystrophy, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of metabolic syndromeOther
Evaluation and analytical determinations of the different components of the syndrome
Evaluation of changes in fat by DXA while on current therapyOther
Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
Prevalence of the different components of this syndrome: Abdominal obesity: waist circumference ≥102 cm in men and ≥88 cm in women, hypertriglyceridemia: ≥150 mg/dl (1.695 mmol/l), low HDL-C: <40 mg/dl in men and <50 mg/dl in women, high blood pressure (BP): >130/85 mmHg, and high fasting glucose: >110 mg/dl.
Measured: 3 months
Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA
Comparison of changes in visceral and subcutaneous fat during current antiretroviral therapy for patients receiving current antiretroviral regimens and who never received thymidine analogues, didanosine, lopinavir, indinavir, or nelfinavir.
Measured: 6 meses
Secondary outcomes (1)
Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome
Correlations of visceral fat by DXA with fat accumulation, hypertension, diabetes or hypertriglyeceridemia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jose L Casado, MD, Principal investigator, Ramon y Cajal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614027
- Sponsor's protocol ID
- 460/15
- Other IDs
- EC 460/15
- Acronym
- METALIP
- Status last verified
- Jun 2018
- First submitted
- 21 Nov 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT02614027
- Acronym / sponsor ID
- METALIP / 460/15
- Conditions
- Lipodystrophy, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades InfecciosasResearch network
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 25 Nov 2015 (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.
To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.
Detailed description
Cross-sectional evaluation of two groups of patients:
- patients receiving currently available drugs, in order to determine the changes in fat accumulation by successive dual X-ray absorptiometry (DXA) determinations
- patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance (insulin resistance or diabetes), fat accumulation (waist circumference) and hypertriglyceridemia.
The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.
Key inclusion criteria (4 listed)
- HIV infection
- Older than 18 years
- Receiving first or second antiretroviral regimen or
- Previous evaluation and classification of lipodystrophy syndrome
Key exclusion criteria (3 listed)
- Pregnancy
- Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids or hormones before inclusion
- Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)
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 |
|---|---|---|
| Evaluation of metabolic syndromeEvaluation and analytical determinations of the different components of the syndrome | Other | – |
| Evaluation of changes in fat by DXA while on current therapyComparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation | Other | – |
Primary outcome
Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
Time frame: 3 months
Prevalence of the different components of this syndrome: Abdominal obesity: waist circumference ≥102 cm in men and ≥88 cm in women, hypertriglyceridemia: ≥150 mg/dl (1.695 mmol/l), low HDL-C: <40 mg/dl in men and <50 mg/dl in women, high blood pressure (BP): >130/85 mmHg, and high fasting glucose: >110 mg/dl.
Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA
Time frame: 6 meses
Comparison of changes in visceral and subcutaneous fat during current antiretroviral therapy for patients receiving current antiretroviral regimens and who never received thymidine analogues, didanosine, lopinavir, indinavir, or nelfinavir.
1 secondary outcome
Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome
Time frame: 3 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 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jose L Casado, MD principal investigator
Ramon y Cajal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipodystrophy and Metabolic Syndrome, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
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 3 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 2 Jul 2018. 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 Spain. 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?
Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III) (time frame: 3 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?
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 2 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.