- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713502
Enteropathy and Diabetes in HIV Patients (REEHAD)
The Role of Environmental Enteropathy on HIV Associated Diabetes
Study Overview
Status
Conditions
Detailed Description
This study will investigate if enteropathy is associated with higher risk of diabetes in HIV patients using a cross-sectional study design. To implement it cost-efficiently, investigators will nest it to an ongoing cohort study which investigates risk factors for diabetes and other chronic diseases among HIV patients in Tanzania (the CICADA study) (NCT03106480).
The CICADA study recruited 1947 participants during 2016/2017. These will be followed- up during 2017/2018 and 2018/2019 by which point it is expected that about 1550 participants will be retained in the cohort. Data collection for the current study will coincide with the final CICADA study follow-up. Data on demography, socio-economic status, conventional non-communicable disease risk factors, HIV and TB status, antiretroviral therapy use history, anthropometry, body composition, lipid profile, CD4 count, C-reactive protein, alpha-1-acid glycoprotein, insulin, and diabetes status will be retrieved from CICADA study. Data on gut enteropathy biomarkers i.e plasma citrulline, GLP-1, glucagon like peptide-2 (GLP-2), glucose-dependent insulinotropic polypeptide (GIP), fecal myeloperoxidase (MPO), neopterin, and alpha-1-antitrypsin, intestinal permeability (by 4-sugar test), lipopolysaccharide binding protein, tumor necrosis factor-α receptor, interleukin 6, and fecal elastase (as an indicator of pancreatic function) will be collected solely for this study to investigate the study hypothesis.
Data will be entered in Cspro and managed and analysed in STATA. Both linear and logistic regression will be used to assess the associations between exposure variables (markers of enteropathy) and outcome (diabetes). In addition, causal inference techniques will be used to investigate associations between enteropathy biomarkers and diabetes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Mwanza Region
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Mwanza, Mwanza Region, Tanzania
- NIMR Research Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: Participants who were recruited in CICADA study (NCT03106480) during 2016/2017 and meet the following criteria:
- Aged 18 years or above
- HIV-infected
- HIV-uninfected
- Resident of Mwanza region
- Consent to take part in this study
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of diabetes
Time Frame: January 2019 to December 2019
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Investigators will determine prevalence of diabetes among participants with enteropathy and those without enteropathy
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January 2019 to December 2019
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Prevalence of pre-diabetes
Time Frame: January 2019 to December 2019
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Investigators will determine prevalence of pre-diabetes among participants with enteropathy and those without enteropathy
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January 2019 to December 2019
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dr George PrayGod, MD, PhD, National Institute for Medical Research
- Principal Investigator: Dr Daniel Faurholt-Jepsen, MD, PhD, University of Copenhagen
- Principal Investigator: Prof Suzanne Filteau, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- Brown TT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, Visscher BR, Margolick JB, Dobs AS. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Arch Intern Med. 2005 May 23;165(10):1179-84. doi: 10.1001/archinte.165.10.1179. Erratum In: Arch Intern Med. 2005 Nov 28;165(21):2541.
- 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.
- Prendergast A, Kelly P. Enteropathies in the developing world: neglected effects on global health. Am J Trop Med Hyg. 2012 May;86(5):756-63. doi: 10.4269/ajtmh.2012.11-0743.
- Nazli A, Chan O, Dobson-Belaire WN, Ouellet M, Tremblay MJ, Gray-Owen SD, Arsenault AL, Kaushic C. Exposure to HIV-1 directly impairs mucosal epithelial barrier integrity allowing microbial translocation. PLoS Pathog. 2010 Apr 8;6(4):e1000852. doi: 10.1371/journal.ppat.1000852.
- Klatt NR, Funderburg NT, Brenchley JM. Microbial translocation, immune activation, and HIV disease. Trends Microbiol. 2013 Jan;21(1):6-13. doi: 10.1016/j.tim.2012.09.001. Epub 2012 Oct 11.
- Boden G. Free fatty acids, insulin resistance, and type 2 diabetes mellitus. Proc Assoc Am Physicians. 1999 May-Jun;111(3):241-8. doi: 10.1046/j.1525-1381.1999.99220.x.
- James WP, Coore HG. Persistent impairment of insulin secretion and glucose tolerance after malnutrition. Am J Clin Nutr. 1970 Apr;23(4):386-9. doi: 10.1093/ajcn/23.4.386. No abstract available.
- Indulekha K, Anjana RM, Surendar J, Mohan V. Association of visceral and subcutaneous fat with glucose intolerance, insulin resistance, adipocytokines and inflammatory markers in Asian Indians (CURES-113). Clin Biochem. 2011 Mar;44(4):281-7. doi: 10.1016/j.clinbiochem.2010.12.015. Epub 2011 Jan 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMA2017GSF-1965
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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