Study Results
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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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2019-07-31
2020-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin 3mg once daily at bedtime
Melatonin
Melatonin 3mg once daily at bedtime
Placebo
Placebo 1 tablet once daily at bedtime
Placebo
Placebo 1 tablet once daily at bedtime
Interventions
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Melatonin
Melatonin 3mg once daily at bedtime
Placebo
Placebo 1 tablet once daily at bedtime
Eligibility Criteria
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Inclusion Criteria
* FBS=120-160mg/dl
* HbA1C\<8%
Exclusion Criteria
* 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
20 Years
65 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT-93-7817
Identifier Type: -
Identifier Source: org_study_id
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