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

NCT05591339 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: OP_1576
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

BCG Vaccination Reaction; Diabetes Mellitus

Keywords

BCG; Type-2 diabetes; non-specific effects; Guinea-Bissau

Outcome Measures

Primary Outcomes (2)

• Hba1c

  Hba1c levels at the end of the study period in people with pre-diabetes

  3 years after enrolment

• F-glucose

  F-glucose levels at the end of the study period in people with pre-diabetes

  3 years after enrolment

Secondary Outcomes (2)

• Type-2 diabetes

  3 years after enrolment

• Time to Type-2 diabetes development

  0-3 years after enrolment

Study Arms (2)

BCG vaccine

EXPERIMENTAL

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.

Biological: BCG vaccine (two doses, 4 weeks apart)

Placebo

PLACEBO COMPARATOR

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.

Biological: Saline placebo (Two doses, 4 weeks apart)

Interventions

Saline placebo (Two doses, 4 weeks apart) BIOLOGICAL

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.

Placebo

BCG vaccine (two doses, 4 weeks apart) BIOLOGICAL

BCG vaccine provided intradermally at the upper arm.

BCG vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandim Health Project: lead
• Steno Diabetes Center Copenhagen: collaborator
• University of Southern Denmark: collaborator
• Sydvestjysk Sygehus: collaborator
• University of Coimbra: collaborator

Study Sites (1)

Bandim Health Project

Bissau, 1004, Guinea-Bissau

Location

Related Publications (22)

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• Bjerregaard-Andersen M, Hansen L, da Silva LI, Joaquim LC, Hennild DE, Christiansen L, Aaby P, Benn CS, Christensen K, Sodemann M, Jensen DM, Beck-Nielsen H. Risk of metabolic syndrome and diabetes among young twins and singletons in Guinea-Bissau. Diabetes Care. 2013 Nov;36(11):3549-56. doi: 10.2337/dc12-2653. Epub 2013 Aug 15.

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Related Links

• Bandim Health Project in Guinea-Bissau

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Eugenia Carvalho, PhD

  Center of Neuroscience and Cell Biology, University of Coimbra, Portugal

  STUDY CHAIR

• Lilica Sanca, Bsc

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

• Morten Bjerregaard-Andersen, MD, PhD

  Hospital of Southwest Jutland, Denmark

  PRINCIPAL INVESTIGATOR

• Stine Byberg, MSc, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to treatment. The investigators (or delegated vaccinator, e.g. nurse) administering the BCG vaccine or placebo (saline) will not be blinded. In case of serious adverse events, the participant can be unblinded after consultation with the coordinating PI.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: December 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)