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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

182

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Ibrahim Janahi, MD, FCCP, FRCPCH
  • 電話番号：00974 40032201
  • メール：ijanahi@sidra.org

研究連絡先のバックアップ

  • 名前：Ibrahim Janahi

研究場所

  • カタール
    • Qa
      • Doha、Qa、カタール、26999
        • Sidra Medicine
        • コンタクト：
          • Ibrahim Janahi
        • コンタクト：
          • Ibrahim Janahi, MD, FCCP, FRCPCH
          • 電話番号：40037684
          • メール：IJanahi@sidra.org

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Metformin arm
Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)
薬：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.
プラセボコンパレーター：Placebo arm
Placebo tablets of similar appearance, size, and color as that of metformin
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Prof Ibrahim Janahi

捜査官

  • 主任研究者：Ibrahim Janahi, MD, FCCP, FRCPCH、Chief Medical Officer

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年5月30日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月30日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • SDR100071
  • ARG01-0430-230037 (その他の助成金/資金番号：Qatar Research Development and Innovation (QRDI))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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