Type 2 Diabetes Mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age from 30 to 65 years (both inclusive), of any gender or skin color 2. Patients with a clinical diagnosis of DM2 3. Able and willing to give informed written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with chronic kidney disease, oncoproliferative diseases and pregnant women. 2. Patients with intellectual or psychological dysfunction that does not allow the understanding and compliance with the requirements of the study, according to the criteria of the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin A1c (Hb-A1c) (values ??in %). Measurement time: Day 1 and 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose (values ??in mmol/L obtained from samples of serum). Measurement time: Day 1, 28, 56 and 84. Postprandial glucose (2h) (values ??in mmol/L obtained from samples of serum). Measurement time: Day 1, 28, 56 and 84. Cholesterol (values ??in mmol/L obtained from serum samples). Time of measurement: Day 1 y84. Triglycerides (values ??in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. HDLc (values ??in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. LDLc (values ??in mmol/L obtained from serum samples). Time of measurement: Day 1 and 84. Insulin (values ??in mIU/mL obtained from serum samples). Time of measurement: Day 1 and 84. Creatinine (values ??in µmol/L obtained from serum samples). Time of measurement: Day 1 and 84. LPS (Endotoxin Units/mL obtained from serum samples). Time of measurement: Day 1 and 84. Microbiome analysis (values ??in mIU/mL obtained from feces). Time of measurement: Day 1 and 84. | — |
Countries
Cuba
Contacts
Hermanos Ameijeiras Surgical Clinical Hospital