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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
Sponsor:
Collaborators:
University of Copenhagen
London School of Hygiene and Tropical Medicine
Queen Mary University of London
Information provided by (Responsible Party):
Dr George PrayGod, National Institute for Medical Research, Tanzania

Tracking Information
First Submitted Date October 17, 2018
First Posted Date October 19, 2018
Last Update Posted Date December 19, 2018
Estimated Study Start Date January 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2018)
  • 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
Original Primary Outcome Measures
 (submitted: October 17, 2018)
  • Prevalence of diabetes [ Time Frame: November 2018 to October 2019 ]
    We will determine prevalence of diabetes among participants with enteropathy and those without without enteropathy
  • Prevalence of pre-diabetes [ Time Frame: November 2018 to October 2019 ]
    We will determine prevalence of pre-diabetes among participants with enteropathy and those without without enteropathy
Change History Complete list of historical versions of study NCT03713502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Enteropathy and Diabetes in HIV Patients
Official Title The Role of Environmental Enteropathy on HIV Associated Diabetes
Brief Summary Emerging data suggest that HIV-infected people have disproportionately higher risk of diabetes than HIV-uninfected people. Multiple factors may contribute to elevated diabetes risk including increased prevalence of conventional non-communicable diseases (NCDs) risk factors, use of some antiretroviral drugs regimens, and inflammation and immune activation secondary to environmental- and HIV-enteropathy. To date, enteropathy has been little studied in relation to HIV and diabetes in Sub-Saharan Africa. Enteropathy leads to systemic inflammation which may in turn result in insulin resistance and may reduce secretion of incretins, the gut hormones which stimulate synthesis and secretion of insulin. Both mechanisms could potentially result in higher diabetes risk in HIV patients. This study investigates the hypothesis that among HIV-infected patients environmental enteropathy increase the risk of diabetes. The findings of this study will provide information which could be used as a basis for developing clinical trials to address different aspects of environmental enteropathy in order to reduce the burden of diabetes among HIV-infected populations
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 Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood, stool and urine samples collected for analysis of enteropathy biomarkers
Sampling Method Non-Probability Sample
Study Population Participants will be recruited from HIV-infected patients attending antiretroviral therapy (ART) clinics in Mwanza (Tanzania) as well as from the general population (those who meet the inclusion criteria).
Condition
  • Diabetes
  • Environmental Enteropathy
  • HIV
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 17, 2018)
1947
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: George PrayGod, MD, PhD +255 28 2503012 ext 220 gpraygod@yahoo.com
Contact: Bazil Kavishe, MD, MSc +255 28 2503012 ext 218 basilbkavishe@gmail.com
Listed Location Countries Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number NCT03713502
Other Study ID Numbers TMA2017GSF-1965
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr George PrayGod, National Institute for Medical Research, Tanzania
Study Sponsor National Institute for Medical Research, Tanzania
Collaborators
  • University of Copenhagen
  • London School of Hygiene and Tropical Medicine
  • Queen Mary University of London
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
PRS Account National Institute for Medical Research, Tanzania
Verification Date December 2018