Melatonin's Effects on Treatment Of Diabetes Mellitus (METOD)

April 4, 2019 updated by: Mesbah Shams, MD, Shiraz University of Medical Sciences

The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus

The aim of this study is to assess the efficacy and safety of melatonin in control of blood sugar in patients with type 2 diabetes mellitus (DM).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.

The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of
        • Shahid Motahhari Clinic, Shiraz University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
  • FBS=120-160mg/dl
  • HbA1C<8%

Exclusion Criteria:

  • Melatonin sensitivity
  • Impaired fasting glucose (IFG)
  • Impaired glucose tolerance (IGT)
  • Under Insulin therapy
  • Pregnancy
  • Lactation
  • Diabetic autonomic neuropathy and orthostatic hypotension
  • Renal failure (Creatinin>1.5mg/dl)
  • Diabetic retinopathy
  • Diabetic nephropathy
  • Malignancy
  • Alcohol use
  • Liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
Melatonin 3mg once daily at bedtime
Drug: Melatonin
Melatonin 3mg once daily at bedtime
Placebo Comparator: Placebo
Placebo 1 tablet once daily at bedtime
Drug: Placebo
Placebo 1 tablet once daily at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months
Fasting blood sugar (FBS)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist circumference
Time Frame: 3 months
3 months
Number of patients with adverse events
Time Frame: 3 months
3 months
Serum Insulin
Time Frame: 3 months
3 months
Weight (Body mass index)
Time Frame: 3 months
3 months
Serum aminotransferases
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Kamran Bagheri Lankarani, M.D., Health Policy Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Mesbah Shams, M.D., Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Payam Peymani, Health Policy Research Center, Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-93-7817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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