Metabolic SyndromePhase 2MetSynNCT01038921
Melatonin and the Metabolic Syndrome
A Phase 2 study testing Melatonin in people with Metabolic Syndrome, run by Emory University at 2 sites in United States.
Trial summary
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-79 years.
- Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
- Availability for six months after enrolling in the study.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Shift-workers.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Hospital
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
Read the detailed description
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
- Metabolic Syndrome
- Being tested
- Melatonin, Placebo
- Keywords
- Blood Pressure, Glucose levels, HDL levels, Triglyceride levels, Waist Circumference
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
8 mg dose of Melatonin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin 8mg one hour before bedtime for 10 weeks Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Placebo administered 1 hour before bedtime for 10 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Components
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kutner, Emory University
- Investigators
- Michael H Kutner, PhD, Principal investigator, Emory UniversityAbinav Goyal, M.D., Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038921
- Sponsor's protocol ID
- IRB00014784
- Other IDs
- R21AT004220-01A2
- Acronym
- MetSyn
- Status last verified
- Feb 2015
- First submitted
- 22 Dec 2009
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25937837
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
- ClinicalTrials.gov ID
- NCT01038921
- Acronym / sponsor ID
- MetSyn / IRB00014784
- Conditions
- Metabolic Syndrome
- Keywords
- Blood Pressure, Glucose levels, HDL levels, Triglyceride levels, Waist Circumference
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninMelatonin 8mg one hour before bedtime for 10 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered 1 hour before bedtime for 10 weeks |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30-79 years.
- Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
- Availability for six months after enrolling in the study.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin8 mg dose of Melatonin | Drug | Melatonin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Metabolic Syndrome Components
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25937837Goyal 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.
- Published manuscript describing the study design of Melatonin Supplementation and the Metabolic SyndroneLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Kutner, PhD principal investigator
Emory University
Abinav Goyal, M.D. study director
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Metabolic Syndrome, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome Components (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.