Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes (4T)
Prediabetic State, Insulin Resistance
About this trial
This is an interventional prevention trial for Prediabetic State focused on measuring prediabetes
Eligibility Criteria
Inclusion Criteria:
- Patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Tolerance Glucose Test (OGTT) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
- Patients who accept to participate in the study and sign the informed consent letter.
Exclusion Criteria:
- Patients with diagnosed Type 2 Diabetes previously or detected during the OGTT
- Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin
- Serum creatinine > 1.6 mg/dL
- Hypertriglyceridemia very high (>500 mg/dL)
- Pregnant women
- Altered arterial hypertension (Systolic >180 mmHg or Diastolic >105 mmHg)
- Excessive alcohol intake, acute or chronic
- Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing´s syndrome, thyrotoxicosis
Sites / Locations
- Universidad de GuanajuatoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Empagliflozin + linagliptin + metformin plus lifestyle
Metformin plus lifestyle
Patients are randomized to receive for 12 months Linagliptin 2.5 mg + metformin 850 mg every 12 hours and empagliflozin 12.5 mg + metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week
Patients are randomized to receive for 12 months Metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the complete dose. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week