Diabetes Mellitus and HIV Study in Mwanza

Diabetes Mellitus Clinical Trial

— CICADA  

Official title:

Diabetes and Associated Complications in HIV Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03106480
• Other study ID #: 16-P01-TAN
• Status: Active, not recruiting
• Start date: October 6, 2016
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: National Institute for Medical Research, Tanzania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1947
• Est. completion date: March 31, 2022
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• HIV/AIDS

Locations

Country	Name	City	State
Tanzania	NIMR Research Clinic	Mwanza	Mwanza Region

Sponsors (8)

Lead Sponsor	Collaborator
National Institute for Medical Research, Tanzania	Hindu Mandal Hospital,Tanzania, London School of Hygiene and Tropical Medicine, Rigshospitalet, Denmark, Tanzania Commission for AIDS, Tanzania, University of Bergen, University of Copenhagen, Vanderbilt University

Country where clinical trial is conducted

Tanzania, 

References & Publications (7)

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. — View 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. Review. Erratum in: Int J Epidemiol. 2016 Dec 1;45(6):2210-2211. — View Citation

Florescu D, Kotler DP. Insulin resistance, glucose intolerance and diabetes mellitus in HIV-infected patients. Antivir Ther. 2007;12(2):149-62. Review. — View 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. — View 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. Erratum in: Eur J Clin Nutr. 2016 Apr;70(4):536. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)