NCT07369284尚未招募2 期
Efficacy of Melatonin in Addition to Standard Care in Glycemic Control of Patients With Gestational Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Trial
Obstetrics & Gynecology Hospital of Fudan University0 个研究点目标入组 150 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks
研究概览
简要总结
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:
- Take melatonin or a placebo every day after randomization until delivery
- Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Melatonin
Experimental
- Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.
- 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.
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
- 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.
- Participants will take identical placebo tablets after randomization until delivery.
干预措施: Placebo (Other)
结局指标
主要结局
Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks
时间窗: Baseline (24 to 28 gestational weeks), and 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.
次要结局
- Gestational weight gain in late pregnancy(From baseline until delivery)
- 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)
- Incidence of intervention-related adverse events(From initiation of the intervention until 6 weeks postpartum)
- Impact of melatonin on fetal growth(From baseline until delivery)
- Percentage of time in range, time above range, and time below range measured by CGM(Baseline and 36 to 38 gestational weeks)
研究者
相似试验
招募中
3 期
Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial2023-504728-24-00Region Hovedstadens Psykiatriske, Psykiatrisk Center Kobenhavn255
招募中
不适用
Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing AdenotonsillectomyNCT07345715Tanta University96
招募中
3 期
Melatonin for Chronic back pain2023-503530-41-00Odense University Hospital220
已完成
不适用
Relationship Between Sleep-Wake Quality and Nocturnal Medical OrdersSleep QualityNCT07288775Hospital Clinica Nova51
尚未招募
不适用
Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum CardiomyopathyNCT07334197Tanta University25