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Melatonin and the Metabolic Syndrome

NCT ID: NCT01038921

Last Updated: 2015-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.

Conditions

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Metabolic Syndrome

Keywords

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Blood Pressure Glucose levels HDL levels Triglyceride levels Waist Circumference

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Melatonin

Melatonin 8mg one hour before bedtime for 10 weeks

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

8 mg dose of Melatonin

Placebo

Placebo administered 1 hour before bedtime for 10 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Melatonin

8 mg dose of Melatonin

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Inability to understand informed consent and to cooperate with study procedures.
2. Supplemental intake of melatonin.
3. Current smoking.
4. Current use of calcium channel blockers.
5. Current, planned, or recent (12 months) participation in another clinical trial.
6. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
7. 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
* Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or without use of nasal CPAP), or by a score of 0.80 or higher on the MAP (Multivariate Apnea Prediction), a validated screening algorithm with high positive and negative predictive value for identifying OSA.
8. Shift-workers.
Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Michael Kutner

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael H Kutner, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Abinav Goyal, M.D.

Role: STUDY_DIRECTOR

Emory University

Locations

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Emory Hospital

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25937837 (View on PubMed)

Related Links

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http://www.dovepress.com/design-and-rationale-of-a-randomized-controlled-trial-of-melatonin-sup-peer-reviewed-article-OAJCT-recommendation1

Published manuscript describing the study design of Melatonin Supplementation and the Metabolic Syndrone

Other Identifiers

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R21AT004220-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00014784

Identifier Type: -

Identifier Source: org_study_id