Melatonin's Effects on Treatment Of Diabetes Mellitus

NCT ID: NCT02691897

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2020-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Melatonin 3mg once daily at bedtime

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Melatonin 3mg once daily at bedtime

Placebo

Placebo 1 tablet once daily at bedtime

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet once daily at bedtime

Interventions

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Melatonin

Melatonin 3mg once daily at bedtime

Intervention Type DRUG

Placebo

Placebo 1 tablet once daily at bedtime

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mesbah Shams, MD

Associate professor of Internal Medicine & Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamran Bagheri Lankarani, M.D.

Role: STUDY_CHAIR

Health Policy Research Center, Shiraz University of Medical Sciences

Mesbah Shams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Payam Peymani

Role: PRINCIPAL_INVESTIGATOR

Health Policy Research Center, Shiraz University of Medical Sciences

Locations

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Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Central Contacts

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Mesbah Shams, M.D.

Role: CONTACT

+989171115134

Facility Contacts

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Mesbah Shams, M.D.

Role: primary

+989171115134

Other Identifiers

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CT-93-7817

Identifier Type: -

Identifier Source: org_study_id

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