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

RECRUITINGPhase 4Sponsored by Bandim Health Project
Actively Recruiting
PhasePhase 4
SponsorBandim Health Project
Started2023-12-01
Est. completion2026-08-01
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 64 YearsHealthy volunteers accepted
Inclusion Criteria for BCG trial:

* Ages 18-64
* Planning to continue living in the study area
* F-glucose from 5.6-6.9 mmol/L and HbA1c between 39-47mmol/mol.

Exclusion Criteria for BCG trial:

* HIV infection (an HIV test to be done before enrolment)
* Pregnancy (a pregnancy test to be done before enrolment in women in the childbearing age)
* Chemotherapy

Conditions2

BCG Vaccination ReactionDiabetes Mellitus

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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