NCT02691897

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1 diabetes-mellitus

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

February 22, 2016

Last Update Submit

April 4, 2019

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitusMelatoninBlood GlucoseTherapeuticsPineal gland

Outcome Measures

Primary Outcomes (2)

  • Fasting blood sugar (FBS)

    3 months

  • HbA1c

    3 months

Secondary Outcomes (5)

  • Serum Insulin

    3 months

  • Weight (Body mass index)

    3 months

  • Waist circumference

    3 months

  • Serum aminotransferases

    3 months

  • Number of patients with adverse events

    3 months

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin 3mg once daily at bedtime

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet once daily at bedtime

Drug: Placebo

Interventions

MelatoninDRUG

Melatonin 3mg once daily at bedtime

Melatonin
PlaceboDRUG

Placebo 1 tablet once daily at bedtime

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
  • FBS=120-160mg/dl
  • HbA1C\<8%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kamran Bagheri Lankarani, M.D.

    Health Policy Research Center, Shiraz University of Medical Sciences

    STUDY CHAIR

  • Mesbah Shams, M.D.

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Payam Peymani

    Health Policy Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesbah Shams, M.D.

CONTACT

+989171115134shams@sums.ac.ir

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal Medicine & Endocrinology

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

July 1, 2019

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)