Melatonin's Effects on Treatment Of Diabetes Mellitus

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Melatonin 3mg once daily at bedtime | Drug: Melatonin<br>* Melatonin 3mg once daily at bedtime<br>|
| Placebo Comparator: Placebo<br>Placebo 1 tablet once daily at bedtime | Drug: Placebo<br>* Placebo 1 tablet once daily at bedtime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood sugar (FBS) |  | 3 months | 
| HbA1c |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Melatonin, Blood Glucose, Therapeutics, Pineal gland