DOP: Identification and Characterization of Diabetes in Low-resource Populations

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit (Other)

Overall Status

Recruiting

CT.gov ID

NCT05487079

Collaborator

University of Exeter (Other), British Medical Research Council (Other), Department for International Development, United Kingdom (Other)

11,700

Enrollment

Location

16.4

Anticipated Duration (Months)

713.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The true burden of diabetes in sub-Saharan Africa (SSA) is unknown as most of the countries do not have good quality data. As such, the overall estimate of diabetes prevalence is largely based on modelled estimates, which may not be accurate.

Additionally, there is lack of clear guidance on which method and thresholds to use in the diagnosis of diabetes in African populations unlike in high income countries (HIC) where such guidance is clear. The limited data available shows that diabetes in Africa manifests differently for example occurring at younger age and in relatively lean individuals. Moreover, where the oral glucose tolerance test (OGTT) has been used to screen for diabetes, a significant proportion of individuals have isolated postprandial hyperglycaemia (IPH): The reasons for this differential manifestation are unclear and the diabetes progression of these unique phenotypes (for example in terms of risk of complications is unknown or response to treatment is unknown).

Therefore, the overall aim of this research is to undertake a large study to determine the true prevalence of diabetes and identify/characterize the different phenotypes; 2) establish a cohort patients with diabetes to understand the natural course of these different phenotypes, including how they respond to treatment (i.e. do the IPH or thin diabetics progress at the same rate as obese, and are the currently used intervention/therapeutic approaches equally effective in the different phenotypes?).

We expect these data to be of direct relevance to an improved understanding of the cause and disease progression of diabetes, performance of diagnostic tests and management of diabetes in SSA, and ultimately lead to better outcomes and wellbeing of patients and increased productivity.

Condition or Disease	Intervention/Treatment	Phase
Diabetes

Study Design

Study Type:

Observational

Anticipated Enrollment :

11700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Identification and Characterization of Diabetes in Low-resource Populations

Actual Study Start Date :

Jan 17, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Diabetic Diabetes defined as below (any or combination): 2h-OGTT: ≥ 11.1 mmol/L FPG: ≥ 7.0 mmol/L HbA1c; ≥ 48 mmol/mol (6.5%)
Pre-Diabetic Prediabetes will be defined as as below (any or combination) 2h- OGTT is between 140 and 199 mg/dL (7.8-11.0 mmol/L) FPG values is between 100 and 125 mg/dL (5.6-6.9 mmol/L) HbA1c is between 42 and 47 mmol/mol (6.0 - 6.4%)
Non-Diabetics Normal glucose tolerance (NGT) HbA1c; < 42 mmol/mol FPG; < 100 mg/dL (5.6 mmol/L) and 2-h PG; < 140 mg/dL (7.8 mmol/L).

Outcome Measures

Primary Outcome Measures

Prevalence of diabetes and prediabetes in a population-based cohort [2 years]
To determine the prevalence of diabetes defined by HbA1c, FPG and OGTT glucose To assess the reproducibility of the different diagnostic tests.
Identification and characterization of the different phenotypes of type 2 diabetes [2 years]

Secondary Outcome Measures

Establishment of a base-line cohort of well-characterized people with diabetes [2 years]
Identify and recruit a cohort of non-diabetic volunteers (including prediabetes i.e., at high risk of developing diabetes) for longitudinal follow-up [2 years]
i. To identify a cohort of non-diabetic people in order to measure the incidence of disease in the future estimate incidence of diabetes. ii. To assess the burden and rates of progression of vascular complications associated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Age ≥ 18 years Signed informed consent
Willing to provide written informed consent

Exclusion Criteria:

Pregnant women - can participate six months after childbirth
Living outside the geographical sampling frame for the relevant site
Unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MRC/UVRI and LSHTM Uganda Research Unit	Entebbe		Uganda

Sponsors and Collaborators

MRC/UVRI and LSHTM Uganda Research Unit
University of Exeter
British Medical Research Council
Department for International Development, United Kingdom

Investigators

Principal Investigator: Moffat Nyirenda, PhD, MRC/UVRI AND LSHTM UGANDA and London School of Hygiene and Tropical Medicine
Principal Investigator: Anxious J Niwaha, MSc, MRC/UVRI AND LSHTM UGANDA