Clinical Trials

MainTitle

Diabetes Mellitus and HIV Study in Mwanza (CICADA)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2017 by Dr George PrayGod, National Institute for Medical Research, Tanzania

Sponsor
National Institute for Medical Research, Tanzania

Collaborator
University of Copenhagen
Rigshospitalet, Denmark
London School of Hygiene and Tropical Medicine
University of Bergen
Vanderbilt University
Tanzania Commission for AIDS, Tanzania
Hindu Mandal Hospital,Tanzania

Information provided by (Responsible Party)
Dr George PrayGod, National Institute for Medical Research, Tanzania

ClinicalTrials.gov Identifier
NCT03106480

First received: February 15, 2017
Last updated: April 3, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

Emerging evidence from high-income countries suggests that diabetes mellitus is become a major health problem among HIV-infected patients. However, due to differences in social, environmental, and genetic factors data from high-income countries can not be extrapolated directly to low-income countries. This study investigates HIV, ART, inflammation, and body composition changes as risk factors for diabetes mellitus among HIV-infected patients in Tanzania.

Condition
Diabetes Mellitus
HIV/AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes and Associated Complications in HIV Patients

Further study details as provided by Dr George PrayGod, National Institute for Medical Research, Tanzania:

Primary Outcome Measures

  • Combined prevalence of pre-diabetes and diabetes [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine the combined prevalence of pre-diabetes and diabetes according to World Health Organization (WHO) diagnosis guidelines and investigate if behavioural and socio-demographic factors, and HIV, Tuberculosis (TB), ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure
  • Prevalence of hypertension [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine the prevalence of hypertension according to WHO diagnosis guidelines and investigate if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure
Secondary Outcome Measures:
  • Combined incidence of pre-diabetes and diabetes [ Time Frame: Follow-up (12 and 24 months) ]
    The investigators will determine the combined incidence of pre-diabetes and diabetes. The number of patients meeting WHO diagnostic criteria of pre-diabetes and those meeting WHO diagnostic criteria for diabetes will added together and become the numerator whereas participants who are not pre-diabetic or diabetic at the beginning of the observation period will constitute the denominator. Investigators will determine if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure
  • Prevalence of dyslipidaemia [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine prevalence of dyslipidaemia based on WHO diagnosis guidelines and investigate if HIV and ART increase the risk of the outcome measure
  • Prevalence of diabetes clinical complications [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine prevalence of diabetes clinical complications and investigate if HIV and ART increase or modify the risk of the outcome measure
  • Level of insulin resistance [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine level of insulin resistance and investigate if HIV and ART are associated with the outcome measure
  • Level of beta-cell function [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine level of beta-cell function and investigate if HIV and ART are associated with the outcome measure
  • Prevalence of diabetes by Fasting Blood Glucose (FBG), Oral Glucose Tolerance Test (OGTT) and Hba1c [ Time Frame: Baseline ]
    By determining the prevalence of diabetes among HIV patients by 3 tests (FBG, OGTT and Hba1c), investigators will be able to judge the test which is best at diagnosing diabetes in HIV-infected populations.
  • Prevalence of sub-clinical atherosclerosis [ Time Frame: Baseline and follow-up (12 and 24 months) ]
    The investigators will determine the prevalence of sub-clinical atherosclerosis and investigate if behavioural and socio-demographic factors, and HIV, TB, ART, dyslipidaemia,chronic immune activation, parasitic infections, and body composition changes increase the risk of the outcome measure

Biospecimen Retention: Samples Without DNA
serum samples

Estimated Enrollment: 1900
Study Start Date: October 6, 2016
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Arms
HIV and Diabetes Cohort
Participants recruited in the study will have diverse characteristics. Participants will either be HIV infected or HIV negative and among those HIV-infected there will be those on ART and those not on ART. In addition, participants will have other background characteristics like having history of tuberculosis treatment, being malnourished while starting ART, having diabetes at ART initiation etc. Investigators will also be able to examine the effect of immune activation, body composition changes, and other related factors on the risk of diabetes. This diversity of characteristics will help provide adequate data to address study outcomes.

Detailed Description:

Access to antiretroviral therapy (ART) is increasing rapidly in low-income countries and HIV-infected patients initiate ART much earlier. As a result, these patients have prolonged life spans and, hence, longer HIV and ART exposure. Emerging data from developed countries suggest that HIV-infected patients have a higher risk than HIV-uninfected people of developing diabetes mellitus (DM) and other non-communicable diseases. The excess diabetes risk is probably related to multiple factors including HIV-associated inflammation, the use of some antiretroviral therapy (ART) regimens, and body composition changes associated with HIV and ART. As a result, HIV-infected populations may develop DM at a younger age and may have a higher mortality if management is not optimal as may be the case in resource-limited countries of Sub-Saharan Africa (SSA).
Most of the data to-date on HIV and DM are from high-income countries, and data in SSA are few and inconsistent. Because of differences in genetic composition as well as environmental factors including high burden of infectious diseases in resource-limited settings, data from high-income countries cannot be extrapolated and reliably used to improve quality of DM care among HIV patients in SSA. The objective of this study is to investigate if HIV, ART, and body composition changes occurring during ART use are associated with higher risk of DM as well as other risk factors for cardiovascular diseases in Tanzanian patients, and examine if HIV increases the risk of DM associated complications. This study is funded by the Danish Ministry of Foreign Affairs from 2016 to 2021.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

A prospective cohort study with two annual follow-ups will be conducted. This will be based on two existing HIV cohorts i.e. Nutrition, Diabetes and Pulmonary Tuberculosis (TB)/HIV (NUT-TB) (NCT00311298) conducted in Mwanza from 2006-2009 and Nutritional Support for African Adults Starting Antiretroviral Therapy (NUSTART) ( PACTR201106000300631) conducted in Mwanza during 2011-2013 and a new HIV cohort which will be recruited at study initiation. In the New HIV cohort, investigators will recruit both HIV patients and HIV negative participants who will act as controls. These 3 groups will provide about 1900 participants with and without HIV infection to address study objectives.

Criteria

Inclusion Criteria:

  • For existing cohorts, patients should come from NUT-TB or NUSTART Cohorts
  • For New HIV cohort, patients should be HIV positive ART naive, HIV negative participants will be come from the same neighborhood as newly recruited HIV positive patients
  • Age will be 18 years and above
  • Mwanza region residency
  • Not planning to relocate outside Mwanza within the study period


Exclusion Criteria:
  • Very severe illness

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03106480

Contacts

Contact:   George PrayGod, MD, PhD +255 28 2503012 gpraygod@yahoo.com
Contact:   Bazil Kavishe, MD, MSc +255 28 2503012 basilbkavishe@gmail.com

Locations

Tanzania
NIMR Research Clinic Recruiting
Mwanza, Mwanza Region, Tanzania
Contact: Bazil Kavishe, MD, MSc    255 28 2503012    basilbkavishe@gmail.com

Sponsors and Collaborators

National Institute for Medical Research, Tanzania
University of Copenhagen
Rigshospitalet, Denmark
London School of Hygiene and Tropical Medicine
University of Bergen
Vanderbilt University
Tanzania Commission for AIDS, Tanzania
Hindu Mandal Hospital,Tanzania

Investigators

Principal Investigator: George PrayGod, MD, PhD National Institute for Medical Research (NIMR), Tanzania
Principal Investigator: Nyagosya Range, MSc, PhD NIMR, Tanzania
Principal Investigator: Mette F Olsen, MSc, PhD University of Copenhagen
Principal Investigator: Daniel Faurholt-Jepsen, MD, PhD University of Copenhagen
Principal Investigator: Henrik Friis, MD, PhD University of Copenhagen
More Information

More Information


Responsible Party: Dr George PrayGod, Principal Research Scientist, National Institute for Medical Research, Tanzania  
ClinicalTrials.gov Identifier: NCT03106480   History of Changes  
Other Study ID Numbers: 16-P01-TAN  
Study First Received: February 15, 2017  
Last Updated: April 3, 2017  
Individual Participant Data    
Plan to Share IPD: No  

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:

Pre-diabetes
Diabetes Mellitus
HIV
ART
Body composition
Inflammation
Insulin resistance
Beta-cell function
Pre-Hypertension
Hypertension

Additional relevant MeSH terms:
Diabetes Mellitus

ClinicalTrials.gov processed this data on December 13, 2017
This information is provided by ClinicalTrials.gov.