Status:
UNKNOWN
Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes
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 chronic disease that has reached global epidemic proportions due to the growing number of patients in all countries; It has become the disease that causes more chronic and acute c...
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 1700mg every 24 hours. 2. Lifestyle modificat...
Eligibility Criteria
Inclusion
- Patients with prediabetes, defined for the existence of one or both of the following conditions: 1) impaired fasting glucose (Fasting glucose between 100 and 125 mg/dL), 2) impaired glucose tolerance (Glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance test (OGTT)
- Patients who accept to participate in the study and sign the informed consent letter.
Exclusion
- Patients with diagnosed Type 2 Diabetes Mellitus 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 :
July 1 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04134650
Start Date
September 1 2019
End Date
July 1 2020
Last Update
October 25 2019
Active Locations (1)
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1
Universidad de Guanajuato
León, Guanauato, Mexico, 37670