Gestational DiabetesPhase 2MELODYNCT07369284
Melatonin for Glycemic Control in Gestational Diabetes Mellitus
A Phase 2 study testing Melatonin in people with Gestational Diabetes, run by Obstetrics & Gynecology Hospital of Fudan University.
Trial summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 45 years
- Singleton pregnancy
- A diagnosis of GDM from a 75-g OGTT during 24 to 28 gestational weeks, according to the IADPSG criteria, with at least fasting plasma glucose (FPG) ≥ 5.1 mmol/L
- Intending to receive obstetric care and deliver in the study center
- Willing and able to provide written informed consent and follow the study procedure
Who cannot join
- Use of melatonin 1 month before pregnancy or/and during pregnancy
- Night shift work or exposed to jetlag on a regular basis during pregnancy
- Contraindications to melatonin use, including hypersensitive or allergic to melatonin
- Use of antidepressive or antipsychotic medications which can interfere with melatonin metabolism and/or elimination, such as fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors; carbamazepine, rifampicin, and other CYP1A2 inducers; and zaleplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics
- Pre-pregnancy diabetes, including patients diagnosed with diabetes before conception, fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester, typical hyperglycemic symptoms or hyperglycemic crisis with random blood glucose ≥ 11.1 mmol/L
- Other major diseases before gestation, e.g. hypertensive disorders, rheumatology or malignant diseases, infected with hepatitis B or hepatitis C, chronic diseases leading to impaired heart, liver, or renal function
- Major fetal anomalies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Melatonin in Addition to Standard Care in Glycemic Control of Patients With Gestational Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Trial
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM).
The main question it aims to answer is:
Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level?
Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control.
Participants will:
- Take melatonin or a placebo every day after randomization until delivery
- Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
- Conditions
- Gestational Diabetes
- Being tested
- Melatonin, Placebo
- Keywords
- Gestational diabetes, Melatonin, Fasting plasma glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
- Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.
- Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery.
PlaceboOther
- Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.
- Participants will take identical placebo tablets after randomization until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | 1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.
2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery. Receives: Drug: Melatonin |
| Placebo | Placebo comparator | 1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.
2. Participants will take identical placebo tablets after randomization until delivery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks
The primary outcome is defined as the change in FPG levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks. For participants who deliver before 36 gestational weeks, the last available FPG measurement obtained will be used.
Measured: Baseline (24 to 28 gestational weeks), and 36 to 38 gestational weeks
Secondary outcomes (7)
Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks
This outcome is defined as change in HbA1c levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks.
Measured: Baseline and 36 to 38 gestational weeks
Initiation of insulin therapy
This outcome is defined as the proportion of participants requiring initiation of insulin therapy.
Measured: From baseline until delivery
Change in mean glucose levels assessed by continuous glucose monitoring (CGM)
This outcome is defined as the change in mean glucose levels measured by CGM at baseline and before delivery.
Measured: Baseline and 36 to 38 gestational weeks
Gestational weight gain in late pregnancy
This outcome is defined as total gestational weight gain and the rate of weight gain from baseline to the last assessment prior to delivery.
Measured: From baseline until delivery
Incidence of intervention-related adverse events
This outcome is defined as the proportion of participants reporting adverse events potentially related to study intervention, including but not limited to dizziness, hypersomnia, nausea, vomiting and hypoglycemia. Adverse events will be collected from participants' medication diaries and systematically assessed through participant self-report at each antenatal clinic visit.
Measured: From initiation of the intervention until 6 weeks postpartum
Impact of melatonin on fetal growth
The antenatal use of melatonin on estimated fetal growth (grams) will be assessed using ultrasound biometry parameters performed every two to four weeks following trial recruitment until birth.
Measured: From baseline until delivery
Percentage of time in range, time above range, and time below range measured by CGM
This outcome is defined as percentages of time in range, time above range, and time below range measured by CGM at baseline and before delivery.
Measured: Baseline and 36 to 38 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369284
- Sponsor's protocol ID
- 2025-260
- Acronym
- MELODY
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melatonin in Addition to Standard Care in Glycemic Control of Patients With Gestational Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07369284
- Acronym / sponsor ID
- MELODY / 2025-260
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, Melatonin, Fasting plasma glucose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- 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 goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM).
The main question it aims to answer is:
Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level?
Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control.
Participants will:
- Take melatonin or a placebo every day after randomization until delivery
- Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
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: Melatonin1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery. |
| Placebo | Placebo comparator | Other: Placebo1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take identical placebo tablets after randomization until delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18 to 45 years
- Singleton pregnancy
- A diagnosis of GDM from a 75-g OGTT during 24 to 28 gestational weeks, according to the IADPSG criteria, with at least fasting plasma glucose (FPG) ≥ 5.1 mmol/L
- Intending to receive obstetric care and deliver in the study center
- Willing and able to provide written informed consent and follow the study procedure
Key exclusion criteria (7 listed)
- Use of melatonin 1 month before pregnancy or/and during pregnancy
- Night shift work or exposed to jetlag on a regular basis during pregnancy
- Contraindications to melatonin use, including hypersensitive or allergic to melatonin
- Use of antidepressive or antipsychotic medications which can interfere with melatonin metabolism and/or elimination, such as fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors; carbamazepine, rifampicin, and other CYP1A2 inducers; and zaleplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics
- Pre-pregnancy diabetes, including patients diagnosed with diabetes before conception, fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester, typical hyperglycemic symptoms or hyperglycemic crisis with random blood glucose ≥ 11.1 mmol/L
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 |
|---|---|---|
| Melatonin1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery. | Drug | Melatonin |
| Placebo1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take identical placebo tablets after randomization until delivery. | Other | Placebo |
Primary outcome
Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks
Time frame: Baseline (24 to 28 gestational weeks), and 36 to 38 gestational weeks
The primary outcome is defined as the change in FPG levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks. For participants who deliver before 36 gestational weeks, the last available FPG measurement obtained will be used.
7 secondary outcomes
Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks
Time frame: Baseline and 36 to 38 gestational weeks
Initiation of insulin therapy
Time frame: From baseline until delivery
Change in mean glucose levels assessed by continuous glucose monitoring (CGM)
Time frame: Baseline and 36 to 38 gestational weeks
Gestational weight gain in late pregnancy
Time frame: From baseline until delivery
Incidence of intervention-related adverse events
Time frame: From initiation of the intervention until 6 weeks postpartum
Impact of melatonin on fetal growth
Time frame: From baseline until delivery
Percentage of time in range, time above range, and time below range measured by CGM
Time frame: Baseline and 36 to 38 gestational weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Gestational Diabetes, run by Obstetrics & Gynecology Hospital of Fudan University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanting Wu, PhD (8621-17321218018, yanting_wu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks (time frame: Baseline (24 to 28 gestational weeks), and 36 to 38 gestational weeks). 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 27 Jan 2026.