CICADA: Diabetes Mellitus and HIV Study in Mwanza
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV and Diabetes Cohort 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. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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
- 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
- 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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For existing cohorts, patients should come from NUT-TB or NUSTART Cohorts
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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
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Age will be 18 years and above
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Mwanza region residency
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Not planning to relocate outside Mwanza within the study period
Exclusion Criteria:
- Very severe illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NIMR Research Clinic | Mwanza | Mwanza Region | Tanzania |
Sponsors and Collaborators
- National Institute for Medical Research, Tanzania
- 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
Investigators
- Principal Investigator: George PrayGod, MD, PhD, National Institute for Medical Research (NIMR), Tanzania
- Principal Investigator: Nyagosya Range, MSc, PhD, NIMR, Tanzania
- Principal Investigator: Mette F Olsen, MSc, PhD, University of Copenhagen
- Principal Investigator: Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen
- Principal Investigator: Henrik Friis, MD, PhD, University of Copenhagen
Study Documents (Full-Text)
None provided.More Information
Publications
- Ali MK, Magee MJ, Dave JA, Ofotokun I, Tungsiripat M, Jones TK, Levitt NS, Rimland D, Armstrong WS. HIV and metabolic, body, and bone disorders: what we know from low- and middle-income countries. J Acquir Immune Defic Syndr. 2014 Sep 1;67 Suppl 1:S27-39. doi: 10.1097/QAI.0000000000000256. Review.
- Dillon DG, Gurdasani D, Riha J, Ekoru K, Asiki G, Mayanja BN, Levitt NS, Crowther NJ, Nyirenda M, Njelekela M, Ramaiya K, Nyan O, Adewole OO, Anastos K, Azzoni L, Boom WH, Compostella C, Dave JA, Dawood H, Erikstrup C, Fourie CM, Friis H, Kruger A, Idoko JA, Longenecker CT, Mbondi S, Mukaya JE, Mutimura E, Ndhlovu CE, Praygod G, Pefura Yone EW, Pujades-Rodriguez M, Range N, Sani MU, Schutte AE, Sliwa K, Tien PC, Vorster EH, Walsh C, Zinyama R, Mashili F, Sobngwi E, Adebamowo C, Kamali A, Seeley J, Young EH, Smeeth L, Motala AA, Kaleebu P, Sandhu MS; African Partnership for Chronic Disease Research (APCDR). Association of HIV and ART with cardiometabolic traits in sub-Saharan Africa: a systematic review and meta-analysis. Int J Epidemiol. 2013 Dec;42(6):1754-71. doi: 10.1093/ije/dyt198. Review. Erratum in: Int J Epidemiol. 2016 Dec 1;45(6):2210-2211.
- Florescu D, Kotler DP. Insulin resistance, glucose intolerance and diabetes mellitus in HIV-infected patients. Antivir Ther. 2007;12(2):149-62. Review.
- Maganga E, Smart LR, Kalluvya S, Kataraihya JB, Saleh AM, Obeid L, Downs JA, Fitzgerald DW, Peck RN. Glucose Metabolism Disorders, HIV and Antiretroviral Therapy among Tanzanian Adults. PLoS One. 2015 Aug 19;10(8):e0134410. doi: 10.1371/journal.pone.0134410. eCollection 2015.
- PrayGod G, Blevins M, Woodd S, Rehman AM, Jeremiah K, Friis H, Kelly P, Changalucha J, Heimburger DC, Filteau S, Koethe JR. A longitudinal study of systemic inflammation and recovery of lean body mass among malnourished HIV-infected adults starting antiretroviral therapy in Tanzania and Zambia. Eur J Clin Nutr. 2016 Apr;70(4):499-504. doi: 10.1038/ejcn.2015.221. Epub 2016 Jan 20. Erratum in: Eur J Clin Nutr. 2016 Apr;70(4):536.
- PrayGod G, Changalucha J, Kapiga S, Peck R, Todd J, Filteau S. Dysglycemia associations with adipose tissue among HIV-infected patients after 2 years of antiretroviral therapy in Mwanza: a follow-up cross-sectional study. BMC Infect Dis. 2017 Jan 30;17(1):103. doi: 10.1186/s12879-017-2209-z.
- Tien PC, Schneider MF, Cole SR, Levine AM, Cohen M, DeHovitz J, Young M, Justman JE. Antiretroviral therapy exposure and incidence of diabetes mellitus in the Women's Interagency HIV Study. AIDS. 2007 Aug 20;21(13):1739-45.
- 16-P01-TAN