Clinical trial NCT04125784: Lipid Profile and Diabetes Mellitus in People With HIV
Official title: Lipid Profile and Diabetes Risk of HIV Patients Treated by Austrian HIV -Physicians: a 7 Year Follow up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Dyslipidemias
Diabetes Mellitus
Cardiovascular Risk Factor
Keywords: HIV
HIV infection
Dyslipidaemia
Diabetes mellitus
Diabetes mellitus type 2
Cardiovascular Risk factor
Lipid profile
Austria
HIV related treatment
Antiretroviral therapy
Follow-up Study
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Merck Gesellschaft mbH, Austria
First posted: 2019-10-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes only participants who participated in the original study from 2014. These patients are all patients who receive HIV related treatment in an extramural setting and visited their ÖGNÄ-HIV physician for routine control in Vienna/Austria. The original inclusion criteria were: adult (older than 18 years) male and female patients diagnosed and confirmed HIV diagnosis, given written informed consent.

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.

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

Primary outcomes:
measure: Changes in dyslipidemia prevalence from baseline - total cholesterol
timeFrame: 7 years
measure: Changes in dyslipidemia prevalence from baseline- triglycerides
timeFrame: 7 years
measure: Changes in dyslipidemia prevalence from baseline - HDL-cholesterol
timeFrame: 7 years
measure: Changes in dyslipidemia prevalence from baseline - Apolipoprotein B
timeFrame: 7 years
measure: Changes in dyslipidemia prevalence from baseline - LDL-cholesterol
timeFrame: 7 years
measure: Changes in dyslipidemia prevalence from baseline - Non-HDL-Cholesterol
timeFrame: 7 years
measure: Changes from baseline in diabetes mellitus type II prevalence
timeFrame: 7 years
Secondary outcomes:
measure: Description of risk profile for cardiovascular events in the sample population
timeFrame: at follow up recruitment, Day 0
measure: Changes from baseline in drug utilization for PLWHIV
timeFrame: 7 years
measure: Prevalence of diabetes mellitus type 2 in correlation to the prescribed antiretroviral regime during the follow up time
timeFrame: 7 years
measure: Changes from baseline in the lipid profile of patients in correlation to prescribed antiretroviral regime
timeFrame: 7 years
measure: Changes from baseline in therapy prescriptions of patients who were found to have hyperlipidaemia during first study in 2014
timeFrame: 7 years
measure: Documentation of any major cardiovascular events (stroke or heart attack)
timeFrame: during 7 years
measure: Incidence of diabetes mellitus type 2 in patients who were diagnosed found to be insulin resistant in the first study in 2014
timeFrame: 7 years
measure: Changes from baseline in therapeutic regimes within those patients who were identified as having diabetes mellitus type 2 in the first study in 2014
timeFrame: 7 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Schalk:Pichler Gruppenpraxis
Study officials:
affiliation: Medical University of Vienna
name: Thomas E Dorner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: