NCT03713502

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,947

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

3.7 years

First QC Date

October 17, 2018

Last Update Submit

June 28, 2021

Conditions

DiabetesEnvironmental EnteropathyHIV

Keywords

Pre-diabetesDiabetesHIVEnteropathyInflammationMicrobial translocationEndotoxin translocationInsulin resistanceVisceral obesityIncretin hormonesGLP-1GLP-2GIP

Outcome Measures

Primary Outcomes (2)

  • Prevalence of diabetes

    Investigators will determine prevalence of diabetes among participants with enteropathy and those without enteropathy

    January 2019 to December 2019

  • Prevalence of pre-diabetes

    Investigators will determine prevalence of pre-diabetes among participants with enteropathy and those without enteropathy

    January 2019 to December 2019

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Aged 18 years or above
  • HIV-infected
  • HIV-uninfected
  • Resident of Mwanza region
  • Consent to take part in this study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIMR Research Clinic

Mwanza, Mwanza Region, Tanzania

Location

Related Publications (9)

  • 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.

    PMID: 15911733BACKGROUND

  • 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.

    PMID: 26287742BACKGROUND

  • 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.

    PMID: 28137307BACKGROUND

  • 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.

    PMID: 22556071BACKGROUND

  • 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.

    PMID: 20386714BACKGROUND

  • 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.

    PMID: 23062765BACKGROUND

  • 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.

    PMID: 10354364BACKGROUND

  • 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.

    PMID: 5441174BACKGROUND

  • 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.

    PMID: 21219897BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Diabetes MellitusGlucose IntoleranceIntestinal DiseasesInflammationInsulin ResistanceObesity, Abdominal

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Scientist

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

May 1, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

TA(1)