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Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Efficacy of Melatonin in Addition to Standard Care in Glycemic Control of Patients With Gestational Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Trial

NCT07369284•Obstetrics & Gynecology Hospital of Fudan University

View on ClinicalTrials.gov

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). 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

Eligibility

Age

18 - 45 years

Sex

FEMALE

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

Key Dates

Start Date

February 1, 2026

Primary Completion Date

June 1, 2027

Completion Date

August 1, 2027

Last Updated

January 27, 2026

Enrollment

150

ESTIMATED participants

Conditions

Gestational Diabetes

Interventions

Melatonin

DRUG

Placebo

OTHER

Contacts

Yanting Wu, PhD

CONTACT

8621-17321218018 yanting_wu@163.com

The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus

Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes

Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)

Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE