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NCT Number: NCT02614027

Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

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.

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Key information

Conditions

Lipodystrophy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramon y Cajal Hospital

Madrid, 28034, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evaluation of metabolic syndrome

Other

Evaluation and analytical determinations of the different components of the syndrome

Evaluation of changes in fat by DXA while on current therapy

Other

Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Registry information

Official study title

Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients

Acronym: METALIP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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