Identification and Characterization of Diabetes in Low-resource Populations

NCT05487079 | Unknown DMC

• 1 other identifier: RGMN210808
• Study Type: observational
• Target: 11,700
• Locations: 1 country
• Sites: 1

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?). The collected data is likely to be directly relevant to an improved understanding of the cause and progression of diabetes, diagnostic test performance, and diabetes care in SSA, ultimately leading to better patient outcomes and well-being, as well as enhanced productivity.

Conditions

Diabetes

Keywords

Diabetes; Diabetes Complications; Pre-Diabetes; OGTT (Oral Glucose Tolerance Test); Dysglycaemia; LMIC (Low Middle Income Countries); Disease Progression; Treatment Outcomes

Outcome Measures

Primary Outcomes (2)

• Number of participants with diabetes and prediabetes

  To determine the prevalence of diabetes defined by HbA1c, FPG and OGTT glucose To assess the reproducibility of the different diagnostic tests.

  2 years

• Number of distinct phenotypes of type 2 diabetes within this population

  Identification and characterization of the different phenotypes of type 2 diabetes

  2 years

Secondary Outcomes (2)

• Number of individuals with diabetes that develop vascular complications

  2 years

• Rate of progression of vascular disease within this population

  2 years

Study Arms (3)

Diabetic

Diabetes will be defined as below (any or combination): 1. 2h-OGTT: ≥ 11.1 mmol/L 2. FPG (fasting plasma glucose): ≥ 7.0 mmol/L 3. HbA1c; ≥ 48 mmol/mol (6.5%)

Pre-Diabetic

Prediabetes will be defined as as below (any or combination) 1. 2h-OGTT is between 140 and 199 mg/dL (7.8-11.0 mmol/L) 2. FPG values is between 100 and 125 mg/dL (5.6-6.9 mmol/L) 3. HbA1c is between 42 and 47 mmol/mol (6.0 - 6.4%)

Non-Diabetics

Normal glucose tolerance (NGT) 1. 2h-OGTT; \< 140 mg/dL (7.8 mmol/L). 2. FPG; \< 100 mg/dL (5.6 mmol/L) and 3. HbA1c; \< 42 mmol/mol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants are all Individuals aged 18 years or older, residing within the 25 villages of Kyamulibwa sub-county of Kalungu District and Lukaya town and willing to give informed consent.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

MRC/UVRI and LSHTM Uganda Research Unit

Entebbe, Uganda

RECRUITING

Related Publications (1)

• Sekitoleko I, Nakanga WP, Webb E, Mugamba V, Balungi P, Mpairwe B, Terry O, Makanga R, Nabanoba E, Mugisha JO, Kimbugwe G, Nyirenda MJ, Niwaha AJ. Identification and characterisation of diabetes in Uganda: protocol for the nested, population-based 'Diabetes in low-resource Populations' (DOP) Study. BMJ Open. 2023 Sep 13;13(9):e071747. doi: 10.1136/bmjopen-2023-071747.

  PMID: 37709304 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine Plasma Serum Whole Blood

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Glucose Intolerance; Disease Progression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaac Sekitoleko, MSc

CONTACT

256701755373; Isaac.sekitoleko@mrcuganda.org

Viola M Mugamba, MBChB

CONTACT

256754676321; viola.mugamba@mrcuganda.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 4, 2022
• Study Start: January 17, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

UG (1)