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Enteropathy and Diabetes in HIV Patients (REEHAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03713502
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : December 19, 2018
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

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

Condition or disease
Diabetes Environmental Enteropathy HIV

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.

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Study Type : Observational
Estimated Enrollment : 1947 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Prevalence of diabetes [ Time Frame: January 2019 to December 2019 ]
    Investigators will determine prevalence of diabetes among participants with enteropathy and those without enteropathy

  2. 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
Blood, stool and urine samples collected for analysis of enteropathy biomarkers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03713502

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Contact: George PrayGod, MD, PhD +255 28 2503012 ext 220
Contact: Bazil Kavishe, MD, MSc +255 28 2503012 ext 218

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NIMR Research Clinic
Mwanza, Mwanza Region, Tanzania
Sponsors and Collaborators
National Institute for Medical Research, Tanzania
University of Copenhagen
London School of Hygiene and Tropical Medicine
Queen Mary University of London
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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

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Responsible Party: Dr George PrayGod, Principal Research Scientist, National Institute for Medical Research, Tanzania Identifier: NCT03713502    
Other Study ID Numbers: TMA2017GSF-1965
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr George PrayGod, National Institute for Medical Research, Tanzania:
Microbial translocation
Endotoxin translocation
Insulin resistance
Visceral obesity
Incretin hormones
Additional relevant MeSH terms:
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Intestinal Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Digestive System Diseases