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Hormone Therapy

Melatonin for Prediabetes

Phase 3
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

Effect of Melatonin on Cardiometabolic Risk- FULL

Eligible Conditions
  • Prediabetes
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in beta-islet cell function
change in insulin sensitivity
Secondary outcome measures
change in 24 hour ambulatory blood pressure
change in CC family chemokine expression
change in IL-6 level
+9 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet identical to Circadin by mouth each day before bedtime for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,612 Previous Clinical Trials
11,470,455 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effect of Melatonin on Cardiometabolic Risk- FULL
John P. Forman 2016. "Effect of Melatonin on Cardiometabolic Risk- FULL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02681887.
All > Osteopenia > Melatonin
~14 spots leftby Apr 2025
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