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

Shiraz University of Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Melatonin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02691897

CT-93-7817

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Melatonin 3mg once daily at bedtime

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

Placebo 1 tablet once daily at bedtime

Treatment:

Drug: Placebo