Status:
ACTIVE_NOT_RECRUITING
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
Lead Sponsor:
University of Guadalajara
Conditions:
PreDiabetes
Impaired Glucose Tolerance
Eligibility:
All Genders
31-60 years
Phase:
PHASE2
Brief Summary
Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin ...
Detailed Description
A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accord...
Eligibility Criteria
Inclusion
- Patients both sexes
- Age between 31 and 60 years
- Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %)
- Body Mass Index from 25 to 34.9 kg/m2
- Stable weight at least the previous last 3 months (weight variation less than 10%)
- Acceptance and signing of informed consent
Exclusion
- History of kidney, liver or heart disease
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Physical impossibility for taking pills
- Hypersensibility to ingredients of intervention
- Consumption of medications or supplements with effects on glucose levels
- Systolic blood pressure ≥ 140 mmHg
- Diastolic blood pressure ≥ 90 mmHg
- HbA1c ≥6.5%
- Triglycerides ≥ 400 mg/dL
- Total cholesterol ≥ 240 mg/dL
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04341571
Start Date
October 24 2019
End Date
July 1 2025
Last Update
October 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico, 44340