Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes

Last updated: September 24, 2019
Sponsor: University of Guadalajara
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03848533
CT-MEL-LESM
  • Ages 30-60
  • All Genders

Study 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 of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. The administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age beween 30 to 60 years old.

  • Diagnosis of Prediabetes state according to the American Diabetes Associationcriteria.

  • Without pharmacological treatment.

  • Body mass index between 25 to 34.9 Kg/m2

  • Sign informed consent

Exclusion

Exclusion Criteria:

  • Patients with pharmacological treatment.

  • Pregnant woman

  • Patients with autoimmune, cancer, reumatic diases history or with pharmaceuticaltreatment

  • 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.

Study Design

Total Participants: 42
Study Start date:
August 22, 2019
Estimated Completion Date:
December 31, 2021

Study 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 patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. The intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. Before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, A1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.

Connect with a study center

  • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

    Guadalajara, Jalisco 44340
    Mexico

    Active - Recruiting

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