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Effectiveness of low fat diet for cholesterol control in patients with antiphospholipid syndrome - APS

Efficacy of the Hypolipid Diet to control Dyslipidemia in patients with Antiphospholipid Syndrome - APS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-56twgz
Enrollment
Unknown
Registered
2020-02-13
Start date
2016-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism and thrombosis of unspecified vein

Interventions

This will be a prospective interventionist study, whose intervention will be the use of a low-fat diet in patients with historical thrombotic Antiphospholipid Syndrome and dyslipidemia. The primary ev
Behavioural

Sponsors

Centro de Hematologia e Hemoterapia de Campinas - Hemocentro
Lead Sponsor
Centro de Hematologia e Hemoterapia de Campinas - Hemocentro
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects were selected from patients diagnosed with thrombosis associated with primary APS, followed at the Hemostasis outpatient clinic of the State University of Campinas (UNICAMP). All patients with primary APS and dyslipidemia who had a history of arterial or venous thrombosis of both sexes, aged over 18 years and diagnosed with dyslipidemia were included. The criteria for the diagnosis of dyslipidemia were: LDL-c above 100mg / dL, HDL-c below 40mg / dL (men) and 50mg / dL (women), TG above 200mg / dL, TC above 190mg / dL , non-HDL cholesterol above 130mg / dL or still on low-fat medications. LDL-c values above 100mg / dL were considered because they were patients with a history of thrombotic disease.

Exclusion criteria

Exclusion criteria: Patients diagnosed with systemic autoimmune disease or neoplasia were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Evaluate whether the low-fat diet is associated with a decrease in Total Cholesterol and non-HDL cholesterol levels, after 6 months of nutritional monitoring with indication of the low-fat diet, by laboratory analysis;;Outcome found 1: Total cholesterol levels decreased significantly after nutritional intervention through the low-fat diet, as did non-HDL cholesterol after 6 months of follow-up.;Expected Outcome 2: Comparison of the mean difference after 6 months of nutritional follow-up through the indication of a low-fat diet, by laboratory analysis, a reduction in LDL-c levels and an increase in HDL-c.;Outcome found 2: There were no significant changes in LDL-c and HDL-c levels in this study

Secondary

MeasureTime frame
There are no secondary outcome in this study

Countries

Brazil

Contacts

Public ContactFernanda;Thays de Andrade Orsi;Rodrigues

Centro de Hematologia e Hemoterapia de Campinas - Hemocentro;Centro de Hematologia e Hemoterapia de Campinas - Hemocentro

nutricao@unicamp.br;thays.ruiz@gmail.com551935218316;1935218316

Outcome results

None listed

Source: REBEC (via WHO ICTRP)