Insulin Resistance, Prediabetic State
Conditions
Keywords
prediabetes
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 + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months
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 program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily On the following parameters, after 12 months of treatment 1\) Glucose metabolism, evaluated by oral glucose tolerance test 2) Insulin resistance evaluated by the oral glucose tolerance 3) Insulin secretion, evaluated by the oral glucose tolerance 4) Pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) Cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy X-ray absorptiometry (DEXA). After the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups. Patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an OGTT. After 12 months , patients will repeat the same evaluation performed at basal.
Interventions
COMBINATION_PRODUCTLinagliptin + metformin and Empagliflozin + metformin
Linagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
DRUGMetformin
Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Sponsors
Hospital Regional de Alta Especialidad del Bajio
Universidad de Guanajuato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Assigned treatments will be delivered to the patients in identical envelopes by a person not involved in the trial; persons who evaluate the follow-up and outcomes will be masked to the treatment allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months | 6 and 12 months | Fasting and post-2h OGTT glucose values (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from basal pancreatic beta cell function at 6 and 12 months | 6 and 12 months | Evaluated with the measurements of glucose and insulin during the oral glucose tolerance |
| Change from basal insulin sensitivity at 6 and 12 months | 6 and 12 months | Insulin sensitivity evaluated during the oral glucose tolerance test by Matsuda index |
| Change from basal Weight at 6 and 12 months | 6 and 12 months | Weight measurement during the study, in kg |
Countries
Mexico
Contacts
Primary ContactRodolfo Guardado-Mendoza, MDPhD
Outcome results
None listed