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

30 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

182

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Ibrahim Janahi, MD, FCCP, FRCPCH
  • Numero di telefono: 00974 40032201
  • Email: ijanahi@sidra.org

Backup dei contatti dello studio

  • Nome: Ibrahim Janahi

Luoghi di studio

  • Qatar
    • Qa
      • Doha, Qa, Qatar, 26999
        • Sidra Medicine
        • Contatto:
          • Ibrahim Janahi
        • Contatto:
          • Ibrahim Janahi, MD, FCCP, FRCPCH
          • Numero di telefono: 40037684
          • Email: IJanahi@sidra.org

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Metformin arm
Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)
Droga: 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.
Comparatore placebo: Placebo arm
Placebo tablets of similar appearance, size, and color as that of metformin
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Prof Ibrahim Janahi

Investigatori

  • Investigatore principale: Ibrahim Janahi, MD, FCCP, FRCPCH, Chief Medical Officer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 marzo 2028

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • SDR100071
  • ARG01-0430-230037 (Altro numero di sovvenzione/finanziamento: Qatar Research Development and Innovation (QRDI))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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