Lipid Profile and Diabetes Mellitus in People With HIV

NCT ID: NCT04125784

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-02-28

Brief Summary

Traditional risk factors for cardiovascular diseases have been shown to have an even higher impact in the HIV infected population. The original study from 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (namely, dyslipidaemia and diabetes mellitus) in people living with HIV (PLWHIV) in Austria. The aim of this follow up study is to see the progression of our study sample and to see what prevalence levels may be found after 7 years. This epidemiological evaluation is conceptualized to document real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk and to compare with the baseline values from the original study.

Detailed Description

Background: In developed countries, an increase in cardiovascular events and related mortality has been seen; even more prominent in people living with HIV (PLWHIV) as compared to non-HIV control groups. Studies have shown dyslipidaemia and diabetes mellitus type 2 as important risk factors for cardiovascular diseases in PLWHIV.

The original study by this group in 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (dyslipidaemia and diabetes mellitus) in PLWHIV in Austria and identified characteristics associated with these two risk factors. In that previous study dyslipidaemia was diagnosed in 46.3% of cases and half of all the study participants showed an increased insulin resistance. Eight persons (1.6%) fulfilled the criteria for diabetes mellitus type 2.

Purpose: The aim of this follow up study is to see the progression of our study sample and to see what prevalence levels may be found after 7 years. Additionally, a look into previously identified characteristics associated with dyslipidaemia and diabetes mellitus type may provide valuable insight into the temporal effects. Finally, examining resource use this population in terms of medications can provide insights into current practice and its associated costs in Austria, as well as an estimate of the added medication cost of dyslipidaemia and diabetes mellitus type 2 in this population.

It is our aim to close the existing knowledge gap on the role of dyslipidaemia and diabetes mellitus on cardiovascular risk among PLWHIV in Austria. Therefore, the investigation will be carried out by using routine data within minimum additional effort to the study team. The data obtained may serve as a base for future decisions on treatment of the Austrian HIV population.

Study details: Our epidemiologic evaluation documents real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk. The gathered data from approximately 450 originally enrolled patients will be compared with the baseline values analysed in the original study in 2014.

Data collection: Dataset definitions and the minimum dataset will be determined by the study authors. Parameters used and documented must match those that were taken in the original study. These were specified in the case report form (CRF). The data collection and preparation will be done by a student of the Medical University of Vienna (Department of Social and Preventive Medicine) as a part of the graduate thesis.

Enrolment Strategy: Patients will be recruited through the original study sites (2 extramural HIV clinics in Vienna). Original patient lists will be screened through the official Mortality Register of the Statistics Austria, where patients who have died during the follow up period will be identified. Additionally, other patients who decline participation will be asked to give reasons of declining participation.

Data Validation and Data quality: Accurate data are crucial contributors to informative statistical analyses. Missing data will not be systematized.

Quality Control: Source documentation and data accuracy will be verified by site visit(s) in 1 randomly selected site after termination of the enrolment period. 10% of case report forms of the reviewed site will be randomly selected for monitoring.

Conditions

HIV Infections; Dyslipidemias; Diabetes Mellitus; Cardiovascular Risk Factor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lipid-profile

The cohort includes male and female patients diagnosed and confirmed HIV diagnosis who receive HIV related treatment in an extramural setting. All patients are adults (older than 18 years old) and have participated in the original study in 2014.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Only Participants who participated in the previous study
• Adult (older than 18 years)
• male and female patients diagnosed and confirmed HIV diagnosis, given written informed consent

Exclusion Criteria

• No participation in the original study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Gesellschaft mbH, Austria

INDUSTRY

Sponsor Role: collaborator

Moritz Oberndorfer

OTHER

Sponsor Role: lead

Responsible Party

Moritz Oberndorfer

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas E Dorner, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Schalk:Pichler Gruppenpraxis

Vienna, , Austria

Countries

Austria

Other Identifiers

V2_02082019

Identifier Type: -

Identifier Source: org_study_id