Síndrome Metabólica
Conditions
Interventions
Phase I: This is a randomized, controlled, two-arm, double-blind clinical trial. Experimental group: 30 participants with type 2 diabetes mellitus will receive 1 capsule of the probiotic AK001 (1×10^1
Sponsors
Hospital Ana Nery
Fundação Oswaldo Cruz - Instituto Gonçalo Muniz
Eligibility
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals aged 30 to 65 years; of both sexes; with a confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM); participants on stable metformin therapy (for at least 4 weeks at a stable dose); informed consent
Exclusion criteria
Exclusion criteria: Participants not receiving pharmacological treatment for glycemic control; participants who used probiotics and/or prebiotics in the month prior to the study inclusion visit; participants using antibiotics; presence of active autoimmune or infectious diseases; participants using other glucose-lowering agents beyond those permitted by the protocol (metformin); patients using hyperglycemic medications (e.g., glucocorticoids, thiazides, phenytoin, estrogens, beta-blockers, pentamidine, interferon, and others); chronic or acute kidney disease or any other medical condition, according to the investigator’s assessment; chronic pain from causes other than diabetic neuropathy; pregnancy or breastfeeding; allergy to any of the active ingredients or excipients of the product under study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the change in scores on the gastrointestinal symptom rating scale; it is expected to find an absence of, or a low level of, gastrointestinal symptoms after use of the probiotic, confirming its safety.;Assess the frequency of and adverse events occurring during the study ;Evaluate changes in anthropometric data such as weight and Body mass index (BMI) comparing pre treatment and pos treatment results | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess changes in laboratory safety parameters (complete blood count, fasting glucose, fructosamine, glycated hemoglobin (HbA1c), urea, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol and fractions, and triglycerides) by comparing pre- and post-treatment values. It is expected to evaluate whether there were any parameter changes by comparing the active and placebo groups.;Assess the Hospital Anxiety and Depression Scale (HADS), pain, neuropathic pain, and quality of life before and after treatment. It is expected to observe improvement in these symptoms and in the participant’s quality of life in the treatment group. | — |
Countries
BR
Contacts
Public ContactDaniela Dorta
Fundação Oswaldo Cruz - Instituto Gonçalo Muniz
Outcome results
None listed