Clinical trial NCT03106480: Diabetes Mellitus and HIV Study in Mwanza
Official title: Diabetes and Associated Complications in HIV Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
HIV/AIDS
Keywords: Pre-diabetes
Diabetes Mellitus
HIV
ART
Body composition
Inflammation
Insulin resistance
Beta-cell function
Pre-Hypertension
Hypertension
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: University of Copenhagen
name: Rigshospitalet, Denmark
name: London School of Hygiene and Tropical Medicine
name: University of Bergen
name: Vanderbilt University
name: Tanzania Commission for AIDS, Tanzania
name: Hindu Mandal Hospital,Tanzania
First posted: 2017-04-10
Enrollment: 1947
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: A prospective cohort study with two annual follow-ups will be conducted. This will be based on two existing HIV cohorts i.e. Nutrition, Diabetes and Pulmonary Tuberculosis (TB)/HIV (NUT-TB) (NCT00311298) conducted in Mwanza from 2006-2009 and Nutritional Support for African Adults Starting Antiretroviral Therapy (NUSTART) ( PACTR201106000300631) conducted in Mwanza during 2011-2013 and a new HIV cohort which will be recruited at study initiation. In the New HIV cohort, investigators will recruit both HIV patients and HIV negative participants who will act as controls. These 3 groups will provide about 1900 participants with and without HIV infection to address study objectives.

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.

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

Primary outcomes:
measure: Combined prevalence of pre-diabetes and diabetes
timeFrame: Baseline and follow-up (12 and 24 months)
measure: Prevalence of hypertension
timeFrame: Baseline and follow-up (12 and 24 months)
Secondary outcomes:
measure: Combined incidence of pre-diabetes and diabetes
timeFrame: Follow-up (12 and 24 months)
measure: Prevalence of dyslipidaemia
timeFrame: Baseline and follow-up (12 and 24 months)
measure: Prevalence of diabetes clinical complications
timeFrame: Baseline and follow-up (12 and 24 months)
measure: Level of insulin resistance
timeFrame: Baseline and follow-up (12 and 24 months)
measure: Level of beta-cell function
timeFrame: Baseline and follow-up (12 and 24 months)
measure: Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c
timeFrame: Baseline
measure: Prevalence of sub-clinical atherosclerosis
timeFrame: Baseline and follow-up (12 and 24 months)
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: NIMR Research Clinic
state: Mwanza Region
Study officials:
affiliation: National Institute for Medical Research (NIMR), Tanzania
name: George PrayGod, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIMR, Tanzania
name: Nyagosya Range, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Mette F Olsen, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Daniel Faurholt-Jepsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Henrik Friis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.