Enteropathy and Diabetes in HIV Patients (REEHAD)
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|ClinicalTrials.gov Identifier: NCT03713502|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease|
|Diabetes Environmental Enteropathy HIV|
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 :||Observational|
|Estimated Enrollment :||1947 participants|
|Official Title:||The Role of Environmental Enteropathy on HIV Associated Diabetes|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2022|
- Prevalence of diabetes [ Time Frame: January 2019 to December 2019 ]Investigators will determine prevalence of diabetes among participants with enteropathy and those without enteropathy
- Prevalence of pre-diabetes [ Time Frame: January 2019 to December 2019 ]Investigators will determine prevalence of pre-diabetes among participants with enteropathy and those without enteropathy
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713502
|Contact: George PrayGod, MD, PhD||+255 28 2503012 ext firstname.lastname@example.org|
|Contact: Bazil Kavishe, MD, MSc||+255 28 2503012 ext email@example.com|
|NIMR Research Clinic|
|Mwanza, Mwanza Region, Tanzania|
|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|