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

Asociacion para el Estudio de las Enfermedades Infecciosas

Status: Completed

Conditions: Lipodystrophy; Metabolic Syndrome

Treatments: Other: Evaluation of changes in fat by DXA while on current therapy; Other: Evaluation of metabolic syndrome

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02614027

460/15

EC 460/15 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)