NCT01038921

Brief Summary

This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 1, 2014

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

December 22, 2009

Results QC Date

August 13, 2013

Last Update Submit

February 11, 2015

Conditions

Metabolic Syndrome

Keywords

Blood PressureGlucose levelsHDL levelsTriglyceride levelsWaist Circumference

Outcome Measures

Primary Outcomes (1)

  • Metabolic Syndrome Components

    3 years

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin 8mg one hour before bedtime for 10 weeks

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo administered 1 hour before bedtime for 10 weeks

Drug: Placebo

Interventions

MelatoninDRUG

8 mg dose of Melatonin

Melatonin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-79 years.
  • Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
  • Availability for six months after enrolling in the study.

You may not qualify if:

  • Inability to understand informed consent and to cooperate with study procedures.
  • Supplemental intake of melatonin.
  • Current smoking.
  • Current use of calcium channel blockers.
  • Current, planned, or recent (12 months) participation in another clinical trial.
  • Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
  • Presence of any of the following diagnosed health conditions:
  • Active malignancy other than nonmelanoma skin cancer (current therapy for this malignancy,diagnosis within five years of enrollment, recurrence within five years of enrollment, or metastasis)
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Recent (\< 1 year ago) history of heart attack, bypass surgery, angioplasty, or stroke
  • Heart failure (New York Heart Association functional class 3 or 4)
  • On renal dialysis
  • Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate, cyclophosphamide,
  • etc.) or an immunodeficiency syndrome
  • Narcotic or alcohol dependence
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Goyal A, Terry PD, Superak HM, Nell-Dybdahl CL, Chowdhury R, Phillips LS, Kutner MH. Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial. Diabetol Metab Syndr. 2014 Nov 18;6:124. doi: 10.1186/1758-5996-6-124. eCollection 2014.

    PMID: 25937837DERIVED

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was designed as a pilot Phase II cross-over design to study the safety of melatonin and to estimate the effect sizes associated with average changes while subjects were on melatonin versus average changes while subjects were on placebo.

Results Point of Contact

Title
Dr. Abinav Goyal
Organization
Emory University
agoyal4@emory.edu
404-727-8758

Study Officials

  • Michael H Kutner, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Abinav Goyal, M.D.

    Emory University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2012

Study Completion

July 1, 2013

Last Updated

February 27, 2015

Results First Posted

May 1, 2014

Record last verified: 2015-02

Locations

US(2)