Melatonin for Glycemic Control in Gestational Diabetes Mellitus (MELODY)

Obstetrics & Gynecology Hospital of Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Gestational Diabetes

Treatments: Drug: Melatonin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07369284

2025-260

Details and patient eligibility

About

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:

1. Take melatonin or a placebo every day after randomization until delivery
2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo