Improving diabetes management and prevention in Guinea-Bissau using BCG vaccination
Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau
PHASE4 · Bandim Health Project · NCT05591339
This study is testing whether the BCG vaccine can help people with pre-diabetes in Guinea-Bissau manage their blood sugar better and prevent Type 2 diabetes.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Bandim Health Project (other) |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Bissau) |
| Trial ID | NCT05591339 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of the Bacillus Calmette-Guérin (BCG) vaccine on managing and preventing Type 2 diabetes (T2D) in Guinea-Bissau, a country facing significant healthcare challenges. Participants aged 18-64 with pre-diabetes will receive either the BCG vaccine or a saline placebo in a randomized manner. The study will evaluate changes in glycemic control, specifically looking at hemoglobin A1c levels, and aims to explore the non-specific health benefits of BCG vaccination beyond its traditional use. The research addresses a critical gap in diabetes care in a low-income setting where access to treatment is severely limited.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-64 living in Guinea-Bissau with pre-diabetes as indicated by specific glucose and HbA1c levels.
Not a fit: Patients with HIV, those who are pregnant, or individuals undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and cost-effective approach to improve diabetes management and prevention in resource-limited settings.
How similar studies have performed: While studies have shown BCG's effectiveness in Type-1 diabetes, this approach in Type-2 diabetes is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bissau
- Bandim Health Project — Bissau, Guinea-Bissau (RECRUITING)
Study contacts
- Principal investigator: Lilica Sanca, Bsc — Bandim Health Project
- Study coordinator: Eugenia Carvalho, PhD
- Email: eugeniamlcarvalho@gmail.com
- Phone: 965058798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, BCG Vaccination Reaction, BCG, Type-2 diabetes, non-specific effects, Guinea-Bissau