Diabetes Mellitus, HIV/AIDS
Conditions
Keywords
Pre-diabetes, Diabetes Mellitus, HIV, ART, Body composition, Inflammation, Insulin resistance, Beta-cell function, Pre-Hypertension, Hypertension
Brief summary
Emerging evidence from high-income countries suggests that diabetes mellitus is become a major health problem among HIV-infected patients. However, due to differences in social, environmental, and genetic factors data from high-income countries can not be extrapolated directly to low-income countries. This study investigates HIV, ART, inflammation, and body composition changes as risk factors for diabetes mellitus among HIV-infected patients in Tanzania.
Detailed description
Access to antiretroviral therapy (ART) is increasing rapidly in low-income countries and HIV-infected patients initiate ART much earlier. As a result, these patients have prolonged life spans and, hence, longer HIV and ART exposure. Emerging data from developed countries suggest that HIV-infected patients have a higher risk than HIV-uninfected people of developing diabetes mellitus (DM) and other non-communicable diseases. The excess diabetes risk is probably related to multiple factors including HIV-associated inflammation, the use of some antiretroviral therapy (ART) regimens, and body composition changes associated with HIV and ART. As a result, HIV-infected populations may develop DM at a younger age and may have a higher mortality if management is not optimal as may be the case in resource-limited countries of Sub-Saharan Africa (SSA). Most of the data to-date on HIV and DM are from high-income countries, and data in SSA are few and inconsistent. Because of differences in genetic composition as well as environmental factors including high burden of infectious diseases in resource-limited settings, data from high-income countries cannot be extrapolated and reliably used to improve quality of DM care among HIV patients in SSA. The objective of this study is to investigate if HIV, ART, and body composition changes occurring during ART use are associated with higher risk of DM as well as other risk factors for cardiovascular diseases in Tanzanian patients, and examine if HIV increases the risk of DM associated complications. This study is funded by the Danish Ministry of Foreign Affairs from 2016 to 2021.
Interventions
None listed
Sponsors
University of Copenhagen
Rigshospitalet, Denmark
London School of Hygiene and Tropical Medicine
University of Bergen
Vanderbilt University
Tanzania Commission for AIDS, Tanzania
Hindu Mandal Hospital,Tanzania
National Institute for Medical Research, Tanzania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For existing cohorts, patients should come from NUT-TB or NUSTART Cohorts * For New HIV cohort, patients should be HIV positive ART naive, HIV negative participants will be come from the same neighborhood as newly recruited HIV positive patients * Age will be 18 years and above * Mwanza region residency * Not planning to relocate outside Mwanza within the study period
Exclusion criteria
* Very severe illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined prevalence of pre-diabetes and diabetes | Baseline and follow-up (12 and 24 months) | The investigators will determine the combined prevalence of pre-diabetes and diabetes according to World Health Organization (WHO) diagnosis guidelines and investigate if behavioural and socio-demographic factors, and HIV, Tuberculosis (TB), ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure |
| Prevalence of hypertension | Baseline and follow-up (12 and 24 months) | The investigators will determine the prevalence of hypertension according to WHO diagnosis guidelines and investigate if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of diabetes clinical complications | Baseline and follow-up (12 and 24 months) | The investigators will determine prevalence of diabetes clinical complications and investigate if HIV and ART increase or modify the risk of the outcome measure |
| Level of insulin resistance | Baseline and follow-up (12 and 24 months) | The investigators will determine level of insulin resistance and investigate if HIV and ART are associated with the outcome measure |
| Combined incidence of pre-diabetes and diabetes | Follow-up (12 and 24 months) | The investigators will determine the combined incidence of pre-diabetes and diabetes. The number of patients meeting WHO diagnostic criteria of pre-diabetes and those meeting WHO diagnostic criteria for diabetes will added together and become the numerator whereas participants who are not pre-diabetic or diabetic at the beginning of the observation period will constitute the denominator. Investigators will determine if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure |
| Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c | Baseline | By determining the prevalence of diabetes among HIV patients by 3 tests (FBG, OGTT and Hba1c), investigators will be able to judge the test which is best at diagnosing diabetes in HIV-infected populations. |
| Prevalence of sub-clinical atherosclerosis | Baseline and follow-up (12 and 24 months) | The investigators will determine the prevalence of sub-clinical atherosclerosis and investigate if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure |
| Level of beta-cell function | Baseline and follow-up (12 and 24 months) | The investigators will determine level of beta-cell function and investigate if HIV and ART are associated with the outcome measure |
| Prevalence of dyslipidaemia | Baseline and follow-up (12 and 24 months) | The investigators will determine prevalence of dyslipidaemia based on WHO diagnosis guidelines and investigate if HIV and ART increase the risk of the outcome measure |
Countries
Tanzania
Outcome results
None listed