Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Study ID
NCT07369284
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

First listed
Jan 27, 2026
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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 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 ]

Central Contacts

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