Characteristics of Young-onset Diabetes in Sub-Saharan Africa (YODA) Study

NCT05013346 | Unknown

• 1 other identifier: CNO012021
• Study Type: observational
• Target: 1,200
• Locations: 4 countries
• Sites: 4

Brief Summary

Type 1 diabetes has been poorly characterised, with very sparse information available in the literature about the characteristics of the disease in Africa. Atypical young onset diabetes is often reported by clinicians in sub-Saharan Africa, including patients who have the phenotype of type 1 diabetes but do not appear to have an absolute insulin requirement. The onset of type 1 diabetes in many sub-Saharan African populations seem to occur at later ages (20s to 40s) than what is generally seen in Caucasian populations. The investigators seek to characterise young-onset insulin treated diabetes (clinically diagnosed type 1 diabetes) in sub-Saharan Africa;

Conditions

Type 1 Diabetes; Diabetes, Autoimmune

Keywords

Type 1 diabetes, C-peptide, islet auto-antibody, sub-Saharan Africa

Outcome Measures

Primary Outcomes (2)

• Proportion of retained endogenous insulin secretion

  Random non-fasting C-peptide level

  Baseline

• Islet auto-antibody titre and positivity proportions

  GADA, IA-2A, ZnT8A

  Baseline

Secondary Outcomes (1)

• Type 1 diabetes genetic risk score

  Baseline

Interventions

No intervention needed OTHER

No intervention required. Not a clinical trial

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is patients with clinically diagnosed type 1 diabetes or diagnosed with young-onset diabetes who are on permanent insulin therapy and being followed-up at the selected different clinical sites across the three countries. The diagnosis of diabetes must have been made before the age of 30 years.

You may qualify if:

• Clinical diagnosis of type 1 diabetes at age less than 30 years
• Currently use insulin as a permanent treatment
• Able to consent to study

You may not qualify if:

• Refusal to provide written informed consent

Sponsors & Collaborators

• Yaounde Central Hospital: lead
• University of Yaounde 1: collaborator
• University of Exeter: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (4)

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

RECRUITING

School of Pathology, University of Witwatersrand

Johannesburg, Gauteng, South Africa

ACTIVE NOT RECRUITING

Muhimbili National Hospital

Dar es Salaam, Tanzania

RECRUITING

Uganda Virus Research Institute

Entebbe, P.O. Box 49, Uganda

RECRUITING

Related Publications (1)

• Sharp SA, Rich SS, Wood AR, Jones SE, Beaumont RN, Harrison JW, Schneider DA, Locke JM, Tyrrell J, Weedon MN, Hagopian WA, Oram RA. Development and Standardization of an Improved Type 1 Diabetes Genetic Risk Score for Use in Newborn Screening and Incident Diagnosis. Diabetes Care. 2019 Feb;42(2):200-207. doi: 10.2337/dc18-1785.

  PMID: 30655379 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva: 2ml of saliva sample will be provided into a saliva pot (GeneFix Saliva Tube Collector) which will be stored at ambient temperature and shipped to the University of Exeter Medical School where DNA will be extracted and analysed. Whole Blood: 5ml of whole blood will be collected to be used directly for full blood count and A1c determination. Plasma: 10ml of whole blood will be collected into an EDTA tube which will be centrifuged and aliquoted into four (4) 1.8mL cryotubes and stored immediately at minus 80 degrees Celsius pending batch analysis. Serum: 10ml of whole blood will be collected into a plain tube which will be centrifuged and aliquoted into four (4) 1.8mL cryotubes and stored pending batch analysis. Urine: 10ml of Urine will be collected into a urine collection pot, dipstick urinalysis will be performed immediately and 1.8mL of urine will be stored pending batch analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eugene Sobgnwi, MD, PhD

  University of Yaounde 1/ Yaounde Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Sobngwi, MD, PhD

CONTACT

+237 675088750; sobngwieugene@yahoo.fr

Jean-Claude Katte, MD, MSc

CONTACT

+237 677587929; jckatte@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: All data produced during the course of the study are entered and held at the central data management hub with access to all principal study investigators in real time as they are uploaded into the system. The data will be held on the server up to 5 years after the closure of recruitment in 2022.
• Access Criteria: Access to the main data hub which is being controlled by the Global Health Research Group at the University of Exeter will be granted to country principal investigators who can remotely access the database from their different locations with their personal secured credentials.

Locations

ZA (1); UG (1); TA (1); CA (1)