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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Guinea-Bissau
Bandim Health Project
RECRUITING
Bissau
Contact Information
Primary
Eugenia Carvalho, PhD
eugeniamlcarvalho@gmail.com
965058798
Backup
Morten Bjerregaard-Andersen, MD, PhD
Morten.Bjerregaard-Andersen2@rsyd.dk
28112956
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 200
Treatments
Experimental: BCG vaccine
Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (e.g. BCG-Denmark or BCG-Japan) in the skin covering the left upper deltoid muscle. Two doses will be given, 4 weeks apart.~Intervention: Biological BCG-vaccine.
Placebo_comparator: Placebo
Placebo will be 0.1 ml sterile 0.9 % NaCl, which has a similar color as the resuspended BCG vaccine. Two placebo doses will be given, 4 weeks apart.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern Denmark, Steno Diabetes Center Copenhagen, Sydvestjysk Sygehus, University of Coimbra
Leads: Bandim Health Project

This content was sourced from clinicaltrials.gov