Diabetes Mellitus and HIV Study in Mwanza

NCT ID: NCT03106480

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1947 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-06
• Study Completion Date: 2022-03-31

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.

Conditions

Diabetes Mellitus; HIV/AIDS

Study Design

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

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Tanzania Commission for AIDS, Tanzania

UNKNOWN

Sponsor Role: collaborator

Hindu Mandal Hospital,Tanzania

UNKNOWN

Sponsor Role: collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr George PrayGod

Principal Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George PrayGod, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for Medical Research (NIMR), Tanzania

Nyagosya Range, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

NIMR, Tanzania

Mette F Olsen, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Daniel Faurholt-Jepsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Henrik Friis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

NIMR Research Clinic

Mwanza, Mwanza Region, Tanzania

Countries

Tanzania

References

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.

Reference Type: BACKGROUND

PMID: 25117959 (View on PubMed)

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. doi: 10.1097/QAD.0b013e32827038d0.

Reference Type: BACKGROUND

PMID: 17690572 (View on PubMed)

Florescu D, Kotler DP. Insulin resistance, glucose intolerance and diabetes mellitus in HIV-infected patients. Antivir Ther. 2007;12(2):149-62. doi: 10.1177/135965350701200214.

Reference Type: BACKGROUND

PMID: 17503657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26785764 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26287742 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24415610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28137307 (View on PubMed)

Nielsen ST, Kweka B, Praygod G, Filteau S, Olsen MF, Friis H, Faurholt-Jepsen D, Krogh-Madsen R. The incretin effect in type 2 diabetes in a Sub-Saharan African population. Clin Diabetes Endocrinol. 2024 Jul 25;10(1):20. doi: 10.1186/s40842-024-00178-5.

Reference Type: DERIVED

PMID: 39049087 (View on PubMed)

Other Identifiers

16-P01-TAN

Identifier Type: -

Identifier Source: org_study_id