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临床试验/NCT03106480
NCT03106480Unknown不适用

Diabetes and Associated Complications in HIV Patients

National Institute for Medical Research, Tanzania1 个研究点 分布在 1 个国家目标入组 1,947 人开始时间: 2016年10月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,947
试验地点
1
主要终点
Combined prevalence of pre-diabetes and diabetes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Very severe illness

结局指标

主要结局

Combined prevalence of pre-diabetes and diabetes

时间窗: 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

Prevalence of hypertension

时间窗: 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

次要结局

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

研究者

发起方
National Institute for Medical Research, Tanzania
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr George PrayGod

Principal Research Scientist

National Institute for Medical Research, Tanzania

研究点 (1)

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