Type 2 Diabetes Mellitus
Conditions
Interventions
Group I (Experimental): Optibiotic Plus. The patient will receive a capsule of 250 mg of viable and non-viable material (150 mg of viable bacteria). The capsule will be received every 12 hours, by ora
Sponsors
Hermanos Ameijeiras Clinical Surgical Hospital
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Type 2 diabetic and prediabetic individuals from all over the country who attend the specialized consultations of the Hermanos Ameijeiras Hospital, over 18 years of age, without distinction of sex or skin color and who give their consent to participate in the study 2-Diabetic individuals who only have oral antihyperglycemic treatments. 3- Do not ingest probiotics at the time of study recruitment.
Exclusion criteria
Exclusion criteria: 1- Type 2 diabetic individuals with insulin treatment. 2-Individuals with type 1 or other Diabetes. 3- Medical alterations that could simulate the symptoms of Type 2 Diabetes Mellitus (T2DM) 4-Active or uncontrolled co-morbidities (including depression, untreated endocrine diagnosis, recent acute infection), which in the physician's opinion could interfere with the patient's ability to participate in the study. 5-Pregnancy or breastfeeding period. 6-Kidney failure or evidence of substance abuse. 7-Participate in other clinical treatments or improvement of symptoms as a result of treatment interventions three months previously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin A1c (HbA1c) levels (Values expressed in %). Measurement time: At baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting glucose (expressed value in mMol/L). Measurement time: At baseline, 3 months and 6 months 2. Cholesterol (expressed value in mmol/L). Measurement time: At baseline, 3 months and 6 months 3. Triglycerides (expressed value in mmol/L). Measurement time: At baseline, 3 months and 6 months 4. Insulin (expressed value in mUI/ml). Measurement time: At baseline, 3 months and 6 months 5. Homa Index (Insulin Resistance Index) (Insulin levels (Fasting U/ml)* Glucose levels (Fasting mmol/L)/22.5). Measurement time: At baseline, 3 months and 6 months | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
Hermanos Ameijeiras Clinical Surgical Hospital
Outcome results
None listed