Melatonin's Effects on Treatment Of Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— METOD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691897
• Other study ID #: CT-93-7817
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2019
• Est. completion date: July 2020

Study information

• Verified date: April 2019
• Source: Shiraz University of Medical Sciences
• Contact: Mesbah Shams, M.D.
• Phone: +989171115134
• Email: shams[@]sums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Melatonin
Melatonin 3mg once daily at bedtime
• Placebo
Placebo 1 tablet once daily at bedtime

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood sugar (FBS)		3 months
Primary	HbA1c		3 months
Secondary	Serum Insulin		3 months
Secondary	Weight (Body mass index)		3 months
Secondary	Waist circumference		3 months
Secondary	Serum aminotransferases		3 months
Secondary	Number of patients with adverse events		3 months