Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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.
• Другое 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.

Первичные конечные точки

• Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks [Срок оценки: Baseline (24 to 28 gestational weeks), and 36 to 38 gestational weeks]

Вторичные конечные точки (7)

• Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks [Срок оценки: Baseline and 36 to 38 gestational weeks]
• Initiation of insulin therapy [Срок оценки: From baseline until delivery]
• Change in mean glucose levels assessed by continuous glucose monitoring (CGM) [Срок оценки: Baseline and 36 to 38 gestational weeks]
• Gestational weight gain in late pregnancy [Срок оценки: From baseline until delivery]
• Incidence of intervention-related adverse events [Срок оценки: From initiation of the intervention until 6 weeks postpartum]
• Impact of melatonin on fetal growth [Срок оценки: From baseline until delivery]
• Percentage of time in range, time above range, and time below range measured by CGM [Срок оценки: Baseline and 36 to 38 gestational weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07369284 · 2025-260

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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