Diabetes Mellitus and HIV Study in Mwanza

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetes and Associated Complications in HIV Patients

Conditions
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Diabetes Mellitus, HIV/AIDS

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV and Diabetes Cohort<br>Participants recruited in the study will have diverse characteristics. Participants will either be HIV infected or HIV negative and among those HIV-infected there will be those on ART and those not on ART. In addition, participants will have other background characteristics like having history of tuberculosis treatment, being malnourished while starting ART, having diabetes at ART initiation etc. Investigators will also be able to examine the effect of immune activation, body composition changes, and other related factors on the risk of diabetes. This diversity of characteristics will help provide adequate data to address study outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined prevalence of pre-diabetes and diabetes | 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 | Baseline and follow-up (12 and 24 months) | 
| Prevalence of hypertension | 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 | Baseline and follow-up (12 and 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of pre-diabetes and diabetes | 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 | Follow-up (12 and 24 months) | 
| Prevalence of dyslipidaemia | 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 | Baseline and follow-up (12 and 24 months) | 
| Prevalence of diabetes clinical complications | The investigators will determine prevalence of diabetes clinical complications and investigate if HIV and ART increase or modify the risk of the outcome measure | Baseline and follow-up (12 and 24 months) | 
| Level of insulin resistance | The investigators will determine level of insulin resistance and investigate if HIV and ART are associated with the outcome measure | Baseline and follow-up (12 and 24 months) | 
| Level of beta-cell function | The investigators will determine level of beta-cell function and investigate if HIV and ART are associated with the outcome measure | Baseline and follow-up (12 and 24 months) | 
| Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c | 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. | Baseline | 
| Prevalence of sub-clinical atherosclerosis | 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 | Baseline and follow-up (12 and 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pre-diabetes, Diabetes Mellitus, ART, Body composition, Inflammation, Insulin resistance, Beta-cell function, Pre-Hypertension, Hypertension