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

Completed

• Conditions: Lipodystrophy; Metabolic Syndrome

• Registration Number: NCT02614027
• Lead Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas

Brief 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 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 Timeline

• Study First Submitted: 2015-11-21
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Study Start: 2016-02
• Primary Completion: 2018-02
• Status Verified: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain