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

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ClinicalTrials.gov Identifier: NCT02691897
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, Shiraz University of Medical Sciences

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Melatonin Drug: Placebo Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus
Study Start Date : March 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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




Primary Outcome Measures :
  1. Fasting blood sugar (FBS) [ Time Frame: 3 months ]
  2. HbA1c [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Serum Insulin [ Time Frame: 3 months ]
  2. Weight (Body mass index) [ Time Frame: 3 months ]
  3. Waist circumference [ Time Frame: 3 months ]
  4. Serum aminotransferases [ Time Frame: 3 months ]
  5. Number of patients with adverse events [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691897


Locations
Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Kamran Bagheri Lankarani, M.D. Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Principal Investigator: Mesbah Shams, M.D. Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Principal Investigator: Seied Mohammad Hosseini saadi, M.D. Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Principal Investigator: Payam Peymani Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

Responsible Party: Mesbah Shams, MD, Associate professor of Internal Medicine & Endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02691897     History of Changes
Other Study ID Numbers: CT-93-7817
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mesbah Shams, MD, Shiraz University of Medical Sciences:
Diabetes mellitus
Melatonin
Blood Glucose
Therapeutics
Pineal gland

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants