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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Melatonin 3mg once daily at bedtime |
|
| Placebo | Placebo Comparator | Placebo 1 tablet once daily at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Melatonin 3mg once daily at bedtime |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood sugar (FBS) | 3 months | |
| HbA1c | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Insulin | 3 months | |
| Weight (Body mass index) | 3 months | |
| Waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mesbah Shams, M.D. | Contact | +989171115134 | shams@sums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Kamran Bagheri Lankarani, M.D. | Health Policy Research Center, Shiraz University of Medical Sciences | Study Chair |
| Mesbah Shams, M.D. | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Motahhari Clinic, Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Placebo 1 tablet once daily at bedtime |
|
| 3 months |
| Serum aminotransferases | 3 months |
| Number of patients with adverse events | 3 months |
| Payam Peymani | Health Policy Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |