Melatonin for Glycemic Control in Gestational Diabetes Mellitus

NCT07369284 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-260
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gestational Diabetes

Keywords

Gestational diabetes; Melatonin; Fasting plasma glucose

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and 36 to 38 gestational weeks

• Initiation of insulin therapy

  From baseline until delivery

• Change in mean glucose levels assessed by continuous glucose monitoring (CGM)

  Baseline and 36 to 38 gestational weeks

• Gestational weight gain in late pregnancy

  From baseline until delivery

• Incidence of intervention-related adverse events

  From initiation of the intervention until 6 weeks postpartum

Other Outcomes (2)

• Pregnancy complications

  From baseline until the end of follow-up at 6 weeks postpartum

• Perinatal outcomes

  From baseline until the end of follow-up at 6 weeks postpartum

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Melatonin DRUG

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.

Melatonin

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead
• West China Second University Hospital: collaborator

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yanting Wu, PhD

CONTACT

8621-17321218018; yanting_wu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share