Melatonin's Effects on Treatment Of Diabetes Mellitus

Early Phase 1

• Conditions: Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT02691897
• Lead Sponsor: Shiraz University of Medical Sciences

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08
• Study Start: 2019-07
• Primary Completion: 2020-05
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 tablet once daily at bedtime
Melatonin	Melatonin	Melatonin 3mg once daily at bedtime

Primary Outcome Measures

Name	Time	Method
HbA1c	3 months
Fasting blood sugar (FBS)	3 months

Secondary Outcome Measures

Name	Time	Method
Serum Insulin	3 months
Serum aminotransferases	3 months
Waist circumference	3 months
Weight (Body mass index)	3 months
Number of patients with adverse events	3 months

Trial Locations

Locations (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of