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Metformin Treatment for Children With Obesity-associated Asthma (MOACT)

2026年5月30日 更新者：Prof Ibrahim Janahi

The Role of Metformin in Asthma Control in Obese/Overweight Children, a Randomized Placebo Controlled Clinical Trial

The goal of this clinical trial is to learn if metformin can improve asthma control in overweight and obese children with mild, moderate, or severe asthma. It will also evaluate the safety and metabolic effects of metformin in this population. The main questions the study aims to answer are:

1) Does metformin improve asthma control, as measured by the Asthma Control Test (ACT) score? 2) Does metformin improve lung function, reduce asthma exacerbations, and improve metabolic and inflammatory markers in overweight/obese children with asthma? Researchers will compare metformin with a placebo (a look-alike substance that contains no active drug) to see if metformin improves asthma outcomes in overweight/obese children with asthma. Participants will take either metformin or a placebo in addition to their standard asthma treatment during the study period. They will attend scheduled clinic visits for asthma assessments, lung function testing, and safety monitoring. Blood, stool, and saliva samples, along with clinical information, will be collected from participants to assess asthma control, and markers related to metabolism and inflammation. Participants will also complete asthma control questionnaires and report medication use and asthma symptoms throughout the study period.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The study is a randomized, double-blinded, placebo-controlled, parallel- group intervention trial aimed to recruit 182 overweight/obese children aged 10-17 years with mild, moderate, or severe persistent asthma from the outpatient Pediatric Pulmonology Department at Sidra Medicine, Qatar. Participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for the intervention period of 26 weeks. The primary outcome is defined as an increase in the Asthma Control Test (ACT) score at the end of the treatment compared with baseline. Secondary outcomes include a decrease in annual rate of asthma exacerbations and corticosteroid use, as well as change in lung function, and pediatric asthma quality of life questionnaire (PAQLQ) score from baseline. Exploratory outcomes include changes in the body mass index, clinical parameters, plasma cytokine profile, plasma metabolomic and lipidomic profile, blood transcriptomic profile, and microbiome of gut and saliva after metformin/placebo intervention. Statistical analyses of all primary and secondary end points will be performed using intention-to-treat (ITT) principle and per protocol (PP) approaches.

研究类型

介入性

注册 (估计的)

182

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Ibrahim Janahi, MD, FCCP, FRCPCH
  • 电话号码：00974 40032201
  • 邮箱：ijanahi@sidra.org

研究联系人备份

  • 姓名：Ibrahim Janahi

学习地点

  • 卡塔尔
    • Qa
      • Doha、Qa、卡塔尔、26999
        • Sidra Medicine
        • 接触：
          • Ibrahim Janahi
        • 接触：
          • Ibrahim Janahi, MD, FCCP, FRCPCH
          • 电话号码：40037684
          • 邮箱：IJanahi@sidra.org

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participant who are capable of giving assent and parentral consent
  • Male/Female participant aged between10-17 years old,
  • overweight/obese children (Overweight and obesity are defined as BMI equal and above the 85th percentile, and BMI above the 95th percentile for age and sex, respectively).
  • Diagnosed with mild persistent, moderate persistent /severe asthma based on GINA guidelines within the 6 months prior to the recruitment date and having ACT score < 20, residing in Qatar
  • Partcipants on standard asthma therapy for at least the last 6 months prior to the recruitment
  • Participant who are currently not taking part in any other interventional study

Exclusion Criteria:

  • Non-asthma chronic lung disease
  • Broncho-pulmonary dysplasia
  • Inflammatory bowel disease
  • Syndromic disorders (e.g. Down's syndrome, Turner's syndrome)
  • Inborn errors of metabolism
  • Symptomatic or previously symptomatic congenital heart disease
  • Craniofacial abnormalities
  • Primary thoracic cage abnormalities
  • Neuromuscular disorders
  • Swallowing disorders
  • Secondary endocrinopathies causing obesity
  • Renal complications
  • Ongoing treatment for cancer
  • Taking metformin or GLP1 medication less than 3 months of the recruitment date
  • Children diagnosed with type-1 diabetes

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Metformin arm
Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)
药品：Metfomin

Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride). The prolonged release metformin tablets 500 mg (Brand Name: GLUCOLIFE XR ® 500) will be provided by QLife Pharma manufacturer, Doha, Qatar.

Metformin tablet description: White to off white, capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "TL 001" on one side and plain on other side.
安慰剂比较：Placebo arm
Placebo tablets of similar appearance, size, and color as that of metformin
药品：Placebo
Placebo description: 500 mg, white to off white capsule shaped biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "TL 001" on one side and plain on other side. Placebo will be provided by QLife Pharma manufacturer, Doha, Qatar.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
大体时间：26 weeks

The primary outcome measure is the change in the Asthma Control Test (ACT) score after 26 weeks of intervention. The ACT is a validated questionnaire used to assess asthma control, including symptoms such as cough, wheezing, use of bronchodilators, nocturnal symptoms, shortness of breath, and limitations in daily activities.

For participants aged 12-17 years, the ACT score ranges from 0 to 25, where higher scores indicate better asthma control. Scores of 21-25 represent well-controlled asthma, 16-20 indicate poorly controlled asthma, and 0-15 indicate very poorly controlled asthma.

For participants aged 4-11 years, the Childhood Asthma Control Test (C-ACT) score ranges from 0 to 27, where higher scores also indicate better asthma control. Scores of 21-27 represent well-controlled asthma, 13-20 indicate poorly controlled asthma, and 0-12 indicate very poorly controlled asthma.
26 weeks

次要结果测量

结果测量
措施说明
大体时间
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
大体时间：26 weeks
Changes in the annualized asthma exacerbation rate during the intervention period, assessed by the total number of asthma exacerbations experienced per participant per year; lower exacerbation rates indicate better asthma control and improved clinical outcomes.
26 weeks
Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention
大体时间：26 weeks
Change in corticosteroid use during the intervention period, assessed by the frequency and/or dose of corticosteroid medication required by participants; reduced corticosteroid use indicates improved asthma control and better clinical outcomes.
26 weeks
Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention
大体时间：26 weeks
Forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention, assessed as percent predicted FEV1 measured by spirometry; higher percent predicted FEV1 values indicate better pulmonary function and improved asthma control.
26 weeks
Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention
大体时间：26 weeks
Forced vital capacity (FVC) after 26 weeks of intervention, assessed as percent predicted FVC measured by spirometry; higher percent predicted FVC values indicate better lung function and improved respiratory capacity.
26 weeks
Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention
大体时间：26 weeks
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention, assessed using the validated PAQLQ instrument; which measures both physical and emotional impact of asthma. The questionnaire has three domains including asthma symptoms (6 items), emotional function (4 items) and activity limitation (3 items), scale ranging from 1 to 7, where higher scores indicate better quality of life and improved symptom control.
26 weeks

其他结果措施

结果测量
措施说明
大体时间
Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
大体时间：26 weeks
Change in body mass index (BMI) after 26 weeks of intervention, assessed as weight in kilograms divided by height in meters squared (kg/m²); lower BMI values or improvement toward age-appropriate BMI ranges indicate better weight management outcomes.
26 weeks
Assessing the impact of intervention treatment on peripheral blood eosinophil count after 26 weeks of intervention
大体时间：26 weeks
Peripheral blood eosinophil count after 26 weeks of intervention, assessed as the absolute eosinophil count in peripheral blood (cells/µL). Lower eosinophil counts may indicate reduced type 2 inflammation and improved asthma control following the intervention.
26 weeks
Assessing the impact of intervention treatment on fasting plasma glucose after 26 weeks of intervention
大体时间：26 weeks
Fasting plasma glucose after 26 weeks of intervention, assessed by measuring fasting blood glucose concentration in plasma (mmol/L); lower values within the normal reference range indicate improved glycemic control and metabolic status.
26 weeks
Assessing the impact of intervention treatment on fasting insulin levels after 26 weeks of intervention
大体时间：26 weeks
Fasting insulin levels after 26 weeks of intervention, assessed by measuring fasting serum insulin concentration (pmol/L); lower fasting insulin levels within the normal reference range indicate improved insulin sensitivity and metabolic control.
26 weeks
Assessing the impact of intervention treatment on plasma cytokine levels after 26 weeks of intervention
大体时间：26 weeks
Changes in the levels of plasma cytokines including IL-22, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-13, IL-17A, IL-33, and leptin will be measured (pg/mL) after 26 weeks of intervention to evaluate the effect of the treatment on systemic inflammatory responses.
26 weeks
Assessing the impact of intervention treatment on plasma metabolomic and lipidomic profiles after 26 weeks of intervention
大体时间：26 weeks
Plasma metabolomic and lipidomic profiles will be measured as relative concentrations of metabolites and lipids (normalized intensity units) after 26 weeks of intervention to assess changes associated with the treatment.
26 weeks
Assessing the impact of intervention treatment on blood transcriptomic profile after 26 weeks of intervention
大体时间：26 weeks
Blood transcriptomic profile will be measured as normalized fold-change values in gene expression after 26 weeks of intervention to assess transcriptomic changes associated with the treatment.
26 weeks
Assessing the impact of intervention treatment on gut and salivary microbiome profile after 26 weeks of intervention
大体时间：26 weeks
Gut and salivary microbiome profiles will be measured as the relative abundance (%) and diversity indices of microbial taxa at the phylum, genus, and species levels after 26 weeks of intervention.
26 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Prof Ibrahim Janahi

调查人员

  • 首席研究员：Ibrahim Janahi, MD, FCCP, FRCPCH、Chief Medical Officer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月30日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月30日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • SDR100071
  • ARG01-0430-230037 (其他赠款/资助编号：Qatar Research Development and Innovation (QRDI))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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