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

Metabolic Syndrome Clinical Trial

— METALIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614027
• Other study ID #: 460/15
• Secondary ID: EC 460/15
• Status: Completed
• Start date: February 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 use.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lipodystrophy
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Evaluation of metabolic syndrome
Evaluation and analytical determinations of the different components of the syndrome
• Evaluation of changes in fat by DXA while on current therapy
Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	6 meses
Secondary	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	3 months