Status:
UNKNOWN
Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes
Lead Sponsor:
Universidad de Guanajuato
Collaborating Sponsors:
Hospital Regional de Alta Especialidad del Bajio
Conditions:
Prediabetic State
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + met...
Detailed Description
The main goal of this clinical trial is to compare the effect of two different treatments during 12 months: 1. Lifestyle modification program + metformin 850 mg twice daily 2. Lifestyle modification ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04131582
Start Date
September 1 2019
End Date
December 30 2020
Last Update
October 21 2019
Active Locations (1)
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1
Universidad de Guanajuato
León, Guanajuato, Mexico, 37670