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

University of Guadalajara

Status and phase: Unknown; Phase 2

Conditions: PreDiabetes

Treatments: Drug: metformin; Drug: melatonin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03848533

CT-MEL-LESM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups

melatonin plus metformin

Experimental group

Description:

It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days. Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before bedtime) per 90 days.

Treatment:

Drug: melatonin

Drug: metformin

metformin plus placebo

Active Comparator group

Description:

It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days. Will administrate homologated placebo once a day in the night (before bedtime) per 90 days.

Treatment:

Drug: Placebo

Drug: metformin

melatonin plus placebo

Experimental group

Description:

It will be indicate homologated placebo once a day in the morning (before breakfast) per 90 days. Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before sleep) per 90 days.

Treatment:

Drug: Placebo

Drug: melatonin