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Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau

Study acronym: BCGTODM
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary completion date: Aug 1, 2026 to Aug 1, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 1, 2026 to Aug 1, 2029
    • Site details revised
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2023 to Dec 1, 2023
    • Site details revised
    v3
  3. Minor Study description expanded, about 3 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Type 2 diabetes (T2D) will affect \~650 million adults worldwide by 2040 and about as many will have pre-diabetes. Chronic hyperinsulinemia/insulin resistance precedes T2D development. Studies link insulin resistance with chronic inflammation and oxidative stress. In Guinea-Bissau, a low-income country in West Africa, the T2D incidence is largely unknown and there is an acute lack of diabetes doctors, nurses and other diabetes educators. They hardly have access to insulin, and mortality from T2D complications is high. Previous studies by the Bandim Health Project (www.bandim.org) in the country show that the Bacillus Calmette-Guérin (BCG) vaccine has non-specific effects, well beyond tuberculosis prevention, conferring a general protection against unrelated pathogens. At the same time, studies from the US have also shown that BCG can significantly improve glycemic control in Type-1 diabetes (T1D) patients. Yet, no such studies have been done in T2D or pre-diabetes. The purpose of the present study is to administer BCG to patients with pre-diabetes, in order to reduce hyperinsulinemia/chronic inflammation, a novel strategy to flatten the growing T2D incidence.
Trial Details
NCT Number NCT05591339
Lead Sponsor Bandim Health Project
Collaborators: University of Coimbra, Steno Diabetes Center Copenhagen, University of Southern Denmark, Sydvestjysk Sygehus
Conditions
(from sponsor)
Diabetes Mellitus, BCG Vaccination Reaction
Related terms Diabetes Mellitus
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov