Status:
UNKNOWN
Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes
Lead Sponsor:
University of Guadalajara
Conditions:
PreDiabetes
Eligibility:
All Genders
30-60 years
Phase:
PHASE2
Brief Summary
Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction o...
Detailed Description
A randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the American Diabetes Association criteria. The patie...
Eligibility Criteria
Inclusion
- Age beween 30 to 60 years old.
- Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
- Without pharmacological treatment.
- Body mass index between 25 to 34.9 Kg/m2
- Sign informed consent
Exclusion
- Patients with pharmacological treatment.
- Pregnant woman
- Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
- Workers on night or changing shifts.
- Subjects that have been exposed to radiation
- Dyslipidemia: Total cholesterol \>250mg/dL, Triglycerides \>500 mg/dL.
- Subjects that have travel to other place with a different time zone.
- Patients with diagnosis of insomnia
- Patients with a glomerular filtration \<60 ml/min using the Cockroft-Gault Formula.
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03848533
Start Date
August 22 2019
End Date
December 1 2021
Last Update
September 26 2019
Active Locations (1)
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1
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico, 44340