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Diabetes Mellitus and HIV Study in Mwanza (CICADA)

28 juni 2021 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1947

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Combined prevalence of pre-diabetes and diabetes
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Combined incidence of pre-diabetes and diabetes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute for Medical Research, Tanzania

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 oktober 2016

Primärt slutförande (Faktisk)

30 december 2019

Avslutad studie (Förväntat)

31 mars 2022

Studieregistreringsdatum

Först inskickad

15 februari 2017

Först inskickad som uppfyllde QC-kriterierna

3 april 2017

Första postat (Faktisk)

10 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 16-P01-TAN

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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