Diabetes Mellitus Clinical Trial
— BCGTODMOfficial title:
Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 1, 2026 |
Est. primary completion date | August 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Project | Bissau |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project | Steno Diabetes Center Copenhagen, Sydvestjysk Sygehus, University of Coimbra, University of Southern Denmark |
Guinea-Bissau,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hba1c | Hba1c levels at the end of the study period in people with pre-diabetes | 3 years after enrolment | |
Primary | F-glucose | F-glucose levels at the end of the study period in people with pre-diabetes | 3 years after enrolment | |
Secondary | Type-2 diabetes | Confirmed Type-2 diabetes at the end of the study period in people with pre-diabetes | 3 years after enrolment | |
Secondary | Time to Type-2 diabetes development | Number of months between enrolment and development of Type-2 diabetes in people with pre-diabetes | 0-3 years after enrolment |
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