Melatonin in type 2 diabetes

Comparison of the effect of oral melatonin administration with placebo on biochemical parameters associated with diabetes in diabetes mellitus Type 2 patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121021011192N4

Enrollment

Registered

2018-01-06

Start date

2017-12-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes. Type 2 diabetes mellitus without complications

Interventions

Intervention 1: Intervention group: Addition of melatonin tablet orally 6 mg/d to for 2 weeks Type 2 diabetes regimen for 2 months. Intervention 2: Control group: Addition of melatonin placebo tablet

Treatment - Drugs

Placebo

Intervention group: Addition of melatonin tablet orally 6 mg/d to for 2 weeks Type 2 diabetes regimen for 2 months

Control group: Addition of melatonin placebo tablet orally 6 mg/d to for 2 weeks Type 2 diabetes regimen for 2 months

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Type 2 diabetes based on ADA (American Diabetes Association) 2017 guideline Age more than 18 years old

Exclusion criteria

Exclusion criteria: History of confirmed hypersensitivity reaction to melatonin or any parts of formulation eGFR less than 30 ml/min/1.73m2 Liver failure (child pugh B, C) Pregnancy & lactation Uncontrolled seizure & untreated major depressive disorder Concurrent use of fluvoxamine & nifedipine

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin A1C serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in fasting blood suger level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in percent of HOMA_IR. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in percent of HOMA_Beta. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in melatonin serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total L.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total H.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total triglyceride serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total high sensitivity CRP serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.	—

Measure

Time frame

Change in hemoglobin A1C serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in fasting blood suger level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in percent of HOMA_IR. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in percent of HOMA_Beta. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in melatonin serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total L.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total H.D.L cholesterol serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total triglyceride serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in total high sensitivity CRP serum level. Timepoint: Before intervention and 60 -80 days after initiation of daily use of melatonin. Method of measurement: Lab kits.

—

Secondary

Measure	Time frame
Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Naderi

Deputy of research, School of Pharmacy, Shahid Beheshty Universiti of Medical Sciences

naderi@sbmu.ac.ir+98 21 8820 9625

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026