# Identification and characterisation of diabetes in Uganda: protocol for the nested, population-based ‘Diabetes in low-resource Populations’ (DOP) Study

## TL;DR

This study aims to understand diabetes prevalence and risk factors in rural Uganda, improve diagnostic methods, and track disease progression over time.

## Contribution

The study introduces a population-based approach to characterize diabetes in a low-resource setting and evaluate diagnostic test performance.

## Key findings

- The study will determine diabetes prevalence and risk factors in rural Uganda.
- It will assess the effectiveness of HbA1c, OGTT, and fasting glucose tests for diagnosing diabetes.
- Long-term follow-up will track diabetes progression and treatment responses.

## Abstract

Sub-Saharan Africa is experiencing an increasing burden of diabetes, but there are
little reliable data, particularly at the community level, on the true prevalence or why
this condition affects young and relatively lean individuals. Moreover, the detection of
diabetes in Africa remains poor, not only due to a lack of resources but because the
performance of available diagnostic tests is unclear.

This research aims to (1) determine the prevalence and risk factors of diabetes in a
rural Ugandan population, (2) use clinical and biochemical markers to define different
diabetes phenotypes and (3) study the progression of diabetes in this population. We
will also assess the utility of the widely used tests (glycated haemoglobin (HbA1c),
oral glucose tolerance test (OGTT) and fasting glucose) in diagnosing diabetes.

This is a population-based study nested within the longstanding general population
cohort in southwestern Uganda. We will undertake a population survey to identify
individuals with diabetes based on fasting glucose, HbA1c, OGTT results or history of
pre-existing diabetes.

The study intends to enrol up to 11 700 individuals aged 18 years and above,
residing within the study area and not pregnant or within 6 months post-delivery
date. All participants will have detailed biophysical and biochemical/metabolic
measurements. Individuals identified to have diabetes and a random selection of controls
will have repeat tests to test reproducibility before referral and enrolment into a
diabetic clinic. Participants will then be followed up for 1 year to assess the
course of the disease, including response to therapy and diabetes-related
complications.

These data will improve our understanding of the burden of diabetes in Uganda, the risk
factors that drive it and underlying pathophysiological mechanisms, as well as better
ways to detect this condition. This will inform new approaches to improve the prevention
and management of diabetes.

This study protocol was approved by the Uganda Virus Research Institute Research Ethics
Committee (REC) (number: G.C./127/21/09/858), the London School of Hygiene and Tropical
Medicine REC (number: 26638) and the Uganda National Council for Science and Technology
(protocol number: HS1791ES). Written informed consent will be obtained from all
participants before being enrolled on to the study and conducting study-related
procedures. Research findings will be disseminated in policy briefs, seminars, local and
international conferences and publications in peer-reviewed open-access journals. As
part of the dissemination plans, findings will also be disseminated to patient care
groups and to clinicians.

NCT05487079.