Diabetes Mellitus and HIV Study in Mwanza (CICADA)
2021년 6월 28일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
1947
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Mwanza Region
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Mwanza, Mwanza Region, 탄자니아
- NIMR Research Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Combined prevalence of pre-diabetes and diabetes
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Combined incidence of pre-diabetes and diabetes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Henrik Friis, MD, PhD, University of Copenhagen
- 수석 연구원: George PrayGod, MD, PhD, National Institute for Medical Research (NIMR), Tanzania
- 수석 연구원: Nyagosya Range, MSc, PhD, NIMR, Tanzania
- 수석 연구원: Mette F Olsen, MSc, PhD, University of Copenhagen
- 수석 연구원: Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 6일
기본 완료 (실제)
2019년 12월 30일
연구 완료 (예상)
2022년 3월 31일
연구 등록 날짜
최초 제출
2017년 2월 15일
QC 기준을 충족하는 최초 제출
2017년 4월 3일
처음 게시됨 (실제)
2017년 4월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 28일
마지막으로 확인됨
2021년 6월 1일
추가 정보
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