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Diabetes Mellitus and HIV Study in Mwanza (CICADA)

28 juni 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

1947

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Tanzania
    • Mwanza Region
      • Mwanza, Mwanza Region, Tanzania
        • NIMR Research Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Combined prevalence of pre-diabetes and diabetes
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)
Prevalence of hypertension
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Combined incidence of pre-diabetes and diabetes
Tijdsspanne: Follow-up (12 and 24 months)
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)
Prevalence of dyslipidaemia
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)
Prevalence of diabetes clinical complications
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)
Level of insulin resistance
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)
Level of beta-cell function
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)
Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c
Tijdsspanne: Baseline
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
Prevalence of sub-clinical atherosclerosis
Tijdsspanne: Baseline and follow-up (12 and 24 months)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute for Medical Research, Tanzania

Medewerkers

London School of Hygiene and Tropical Medicine
Rigshospitalet, Denmark
University of Copenhagen
University of Bergen
Vanderbilt University
Tanzania Commission for AIDS, Tanzania
Hindu Mandal Hospital,Tanzania

Onderzoekers

  • Hoofdonderzoeker: Henrik Friis, MD, PhD, University of Copenhagen
  • Hoofdonderzoeker: George PrayGod, MD, PhD, National Institute for Medical Research (NIMR), Tanzania
  • Hoofdonderzoeker: Nyagosya Range, MSc, PhD, NIMR, Tanzania
  • Hoofdonderzoeker: Mette F Olsen, MSc, PhD, University of Copenhagen
  • Hoofdonderzoeker: Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 oktober 2016

Primaire voltooiing (Werkelijk)

30 december 2019

Studie voltooiing (Verwacht)

31 maart 2022

Studieregistratiedata

Eerst ingediend

15 februari 2017

Eerst ingediend dat voldeed aan de QC-criteria

3 april 2017

Eerst geplaatst (Werkelijk)

10 april 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2021

Laatste update ingediend die voldeed aan QC-criteria

28 juni 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-P01-TAN

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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