Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances (METALIP)

June 29, 2018 updated by: Asociacion para el Estudio de las Enfermedades Infecciosas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Ramón y Cajal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • HIV infection
  • Older than 18 years
  • Receiving first or second antiretroviral regimen or
  • Previous evaluation and classification of lipodystrophy syndrome

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
6 meses

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome
Time Frame: 3 months
Correlations of visceral fat by DXA with fat accumulation, hypertension, diabetes or hypertriglyeceridemia
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Investigators

  • Principal Investigator: Jose L Casado, MD, Ramón y Cajal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

November 21, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 460/15
  • EC 460/15 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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