Diabetes Mellitus and HIV Study in Mwanza (CICADA)
2021年6月28日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
1947
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Mwanza Region
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Mwanza、Mwanza Region、坦桑尼亚
- NIMR Research Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Combined prevalence of pre-diabetes and diabetes
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Combined incidence of pre-diabetes and diabetes
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Henrik Friis, MD, PhD、University of Copenhagen
- 首席研究员：George PrayGod, MD, PhD、National Institute for Medical Research (NIMR), Tanzania
- 首席研究员：Nyagosya Range, MSc, PhD、NIMR, Tanzania
- 首席研究员：Mette F Olsen, MSc, PhD、University of Copenhagen
- 首席研究员：Daniel Faurholt-Jepsen, MD, PhD、University of Copenhagen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月6日
初级完成 (实际的)
2019年12月30日
研究完成 (预期的)
2022年3月31日
研究注册日期
首次提交
2017年2月15日
首先提交符合 QC 标准的
2017年4月3日
首次发布 (实际的)
2017年4月10日
研究记录更新
最后更新发布 (实际的)
2021年6月29日
上次提交的符合 QC 标准的更新
2021年6月28日
最后验证
2021年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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