Diabetes Mellitus and HIV Study in Mwanza (CICADA)
28 giugno 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
1947
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Mwanza Region
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Mwanza, Mwanza Region, Tanzania
- NIMR Research Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Combined prevalence of pre-diabetes and diabetes
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Combined incidence of pre-diabetes and diabetes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Henrik Friis, MD, PhD, University of Copenhagen
- Investigatore principale: George PrayGod, MD, PhD, National Institute for Medical Research (NIMR), Tanzania
- Investigatore principale: Nyagosya Range, MSc, PhD, NIMR, Tanzania
- Investigatore principale: Mette F Olsen, MSc, PhD, University of Copenhagen
- Investigatore principale: Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 ottobre 2016
Completamento primario (Effettivo)
30 dicembre 2019
Completamento dello studio (Anticipato)
31 marzo 2022
Date di iscrizione allo studio
Primo inviato
15 febbraio 2017
Primo inviato che soddisfa i criteri di controllo qualità
3 aprile 2017
Primo Inserito (Effettivo)
10 aprile 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 giugno 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 giugno 2021
Ultimo verificato
1 giugno 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16-P01-TAN
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .