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Not yet recruiting NCT07369284

Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Phase II Interventional Gestational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Melatonin, Placebo.
Who it may be relevant to
Registry conditions: Gestational Diabetes. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug Melatonin
    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.
  • Other Placebo
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07369284 · 2025-260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗