Diabetes MellitusEarly Phase 1METODNCT02691897
Melatonin's Effects on Treatment Of Diabetes Mellitus
A Early Phase 1 study testing Melatonin in people with Diabetes Mellitus, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jul 2019to Jul 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
- FBS=120-160mg/dl
- HbA1C<8%
Who cannot join
- Melatonin sensitivity
- Impaired fasting glucose (IFG)
- Impaired glucose tolerance (IGT)
- Under Insulin therapy
- Pregnancy
- Lactation
Show all 13Show fewer
- Diabetic autonomic neuropathy and orthostatic hypotension
- Renal failure (Creatinin>1.5mg/dl)
- Diabetic retinopathy
- Diabetic nephropathy
- Malignancy
- Alcohol use
- Liver disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
Mesbah Shams, M.D., +989171115134, shams@sums.ac.ir
About this study
Official title: The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus
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).
Read the detailed description
Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.
The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.
- Conditions
- Diabetes Mellitus
- Being tested
- Melatonin, Placebo
- Keywords
- Diabetes mellitus, Melatonin, Blood Glucose, Therapeutics, Pineal gland
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 3mg once daily at bedtime
PlaceboDrug
Placebo 1 tablet once daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin 3mg once daily at bedtime Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Placebo 1 tablet once daily at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood sugar (FBS)
Measured: 3 months
HbA1c
Measured: 3 months
Secondary outcomes (5)
Serum Insulin
Measured: 3 months
Weight (Body mass index)
Measured: 3 months
Waist circumference
Measured: 3 months
Serum aminotransferases
Measured: 3 months
Number of patients with adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJul 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Kamran Bagheri Lankarani, M.D., Study chair, Health Policy Research Center, Shiraz University of Medical SciencesMesbah Shams, M.D., Principal investigator, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesPayam Peymani, Principal investigator, Health Policy Research Center, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691897
- Sponsor's protocol ID
- CT-93-7817
- Acronym
- METOD
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02691897
- Acronym / sponsor ID
- METOD / CT-93-7817
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Melatonin, Blood Glucose, Therapeutics, Pineal gland
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.
The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninMelatonin 3mg once daily at bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tablet once daily at bedtime |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
- FBS=120-160mg/dl
- HbA1C<8%
Key exclusion criteria (13 listed)
- Melatonin sensitivity
- Impaired fasting glucose (IFG)
- Impaired glucose tolerance (IGT)
- Under Insulin therapy
- Pregnancy
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 |
|---|---|---|
| MelatoninMelatonin 3mg once daily at bedtime | Drug | Melatonin |
| PlaceboPlacebo 1 tablet once daily at bedtime | Drug | Placebo |
Primary outcome
Fasting blood sugar (FBS)
Time frame: 3 months
HbA1c
Time frame: 3 months
5 secondary outcomes
Serum Insulin
Time frame: 3 months
Weight (Body mass index)
Time frame: 3 months
Waist circumference
Time frame: 3 months
Serum aminotransferases
Time frame: 3 months
Number of patients with adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Kamran Bagheri Lankarani, M.D. study chair
Health Policy Research Center, Shiraz University of Medical Sciences
Mesbah Shams, M.D. principal investigator
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Payam Peymani principal investigator
Health Policy Research Center, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin in people with Diabetes Mellitus, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 13 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: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mesbah Shams, M.D. (+989171115134, shams@sums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood sugar (FBS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2019.