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

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.

Conditions

• Diabetes Mellitus
• BCG Vaccination Reaction

Interventions

BIOLOGICAL

BCG vaccine (two doses, 4 weeks apart)

BCG vaccine provided intradermally at the upper arm.

BIOLOGICAL

Saline placebo (Two doses, 4 weeks apart)

Participants randomized to the control group (placebo) will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.

Sponsors & Collaborators

• University of Coimbra

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Sydvestjysk Sygehus

  collaborator UNKNOWN

• Bandim Health Project

  lead OTHER

Principal Investigators

• Eugenia Carvalho, PhD · Center of Neuroscience and Cell Biology, University of Coimbra, Portugal

• Lilica Sanca, Bsc · Bandim Health Project

• Morten Bjerregaard-Andersen, MD, PhD · Hospital of Southwest Jutland, Denmark

• Stine Byberg, MSc, PhD · Steno Diabetes Center Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2027-08-01

Completion

2029-08-01

Countries

• Guinea-Bissau

Study Locations