Diabetes Mellitus and HIV Study in Mwanza (CICADA)
28 de junio de 2021 actualizado por: Dr George PrayGod, National Institute for Medical Research, Tanzania
Diabetes and Associated Complications in HIV Patients
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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
1947
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Mwanza Region
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Mwanza, Mwanza Region, Tanzania
- NIMR Research Clinic
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Combined prevalence of pre-diabetes and diabetes
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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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
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Baseline and follow-up (12 and 24 months)
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Prevalence of hypertension
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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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
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Baseline and follow-up (12 and 24 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Combined incidence of pre-diabetes and diabetes
Periodo de tiempo: Follow-up (12 and 24 months)
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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
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Follow-up (12 and 24 months)
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Prevalence of dyslipidaemia
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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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
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Baseline and follow-up (12 and 24 months)
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Prevalence of diabetes clinical complications
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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The investigators will determine prevalence of diabetes clinical complications and investigate if HIV and ART increase or modify the risk of the outcome measure
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Baseline and follow-up (12 and 24 months)
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Level of insulin resistance
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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The investigators will determine level of insulin resistance and investigate if HIV and ART are associated with the outcome measure
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Baseline and follow-up (12 and 24 months)
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Level of beta-cell function
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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The investigators will determine level of beta-cell function and investigate if HIV and ART are associated with the outcome measure
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Baseline and follow-up (12 and 24 months)
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Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c
Periodo de tiempo: Baseline
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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.
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Baseline
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Prevalence of sub-clinical atherosclerosis
Periodo de tiempo: Baseline and follow-up (12 and 24 months)
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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
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Baseline and follow-up (12 and 24 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Henrik Friis, MD, PhD, University of Copenhagen
- Investigador principal: George PrayGod, MD, PhD, National Institute for Medical Research (NIMR), Tanzania
- Investigador principal: Nyagosya Range, MSc, PhD, NIMR, Tanzania
- Investigador principal: Mette F Olsen, MSc, PhD, University of Copenhagen
- Investigador principal: Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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, 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Int J Epidemiol. 2016 Dec 1;45(6):2210-2211.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de octubre de 2016
Finalización primaria (Actual)
30 de diciembre de 2019
Finalización del estudio (Anticipado)
31 de marzo de 2022
Fechas de registro del estudio
Enviado por primera vez
15 de febrero de 2017
Primero enviado que cumplió con los criterios de control de calidad
3 de abril de 2017
Publicado por primera vez (Actual)
10 de abril de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de junio de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16-P01-TAN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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