Diabetes Mellitus
Conditions
Keywords
Diabetes mellitus, Melatonin, Blood Glucose, Therapeutics, Pineal gland
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.
Interventions
DRUGMelatonin
Melatonin 3mg once daily at bedtime
DRUGPlacebo
Placebo 1 tablet once daily at bedtime
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar (FBS) | 3 months |
| HbA1c | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference | 3 months |
| Serum Insulin | 3 months |
| Number of patients with adverse events | 3 months |
| Serum aminotransferases | 3 months |
| Weight (Body mass index) | 3 months |
Countries
Iran
Contacts
Primary ContactMesbah Shams, M.D.
Outcome results
None listed