Metformin and health, how the use of the drug is related to diseases in patients with Monoclonal Gammopathy in western Paraná

Use of metformin and the occurrence of diseases and injuries in people with positive Monoclonal Gammopathy of Undetermined Significance (MGUS) in the western macroregion of Paraná

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-9p6x9yh

Enrollment

Unknown

Registered

2025-04-16

Start date

2024-08-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Interventions

This is a phase II intervention study lasting three years involving approximately up to 21 participants with a positive diagnosis of Monoclonal Gammopathy of Undetermined Significance who will be foll

D02.078.370.141.450

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: Men; over 50 years old; with positive results for Monoclonal Gammopathy of Undetermined Significance; who accept specialized follow-up at the University Hospital of Western Paraná in Cascavel, Paraná

Exclusion criteria

Exclusion criteria: Men who do not accept monitoring or do not sign the Free and Informed Consent Form will be excluded from the study; men who present intolerance to Metformin; gastrointestinal problems that affect the absorption of the medication; who use medications that can interact significantly with Metformin, for example Carbonic Anhydrase; who undergo immunosuppressive therapies; who undergo recent oncological treatments; with metabolic conditions such as Type 1 Diabetes Mellitus; or those who are unable to follow the study instructions or who do not agree to participate

Design outcomes

Primary

Measure	Time frame
To evaluate the influence of the use of extended-release metformin on the progression of M protein levels in patients with Monoclonal Gammopathy of Undetermined Significance over a three-year follow-up period.	—

Secondary

Measure	Time frame
Investigate the incidence of adverse events related to progression to multiple myeloma or lymphoma, using bone marrow exams and CT scans of the abdomen and chest.;Evaluate changes in laboratory parameters such as blood count, creatinine, calcium, protein electrophoresis and protein immunoelectrophoresis during semi-annual monitoring.;Identify possible correlations between the use of metformin and the occurrence of other clinical problems or adverse events.	—

Measure

Time frame

Investigate the incidence of adverse events related to progression to multiple myeloma or lymphoma, using bone marrow exams and CT scans of the abdomen and chest.;Evaluate changes in laboratory parameters such as blood count, creatinine, calcium, protein electrophoresis and protein immunoelectrophoresis during semi-annual monitoring.;Identify possible correlations between the use of metformin and the occurrence of other clinical problems or adverse events.

—

Countries

Brazil

Contacts

Public ContactMayara Borsa

Universidade Estadual do Oeste do Paraná - UNIOESTE

mayara.borsa@hotmail.com+55(46)999018242

Outcome results

None listed

Source: REBEC (via WHO ICTRP)