Metformin Treatment for Children With Obesity-associated Asthma (MOACT)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Ibrahim Janahi, MD, FCCP, FRCPCH
- Telefonnummer: 00974 40032201
- E-post: ijanahi@sidra.org
Studera Kontakt Backup
- Namn: Ibrahim Janahi
Studieorter
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Qa
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Doha, Qa, Qatar, 26999
- Sidra Medicine
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Kontakt:
- Ibrahim Janahi
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Kontakt:
- Ibrahim Janahi, MD, FCCP, FRCPCH
- Telefonnummer: 40037684
- E-post: IJanahi@sidra.org
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Metformin arm
Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)
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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. |
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Placebo-jämförare: Placebo arm
Placebo tablets of similar appearance, size, and color as that of metformin
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
Tidsram: 26 weeks
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on peripheral blood eosinophil count after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
|
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Assessing the impact of intervention treatment on fasting plasma glucose after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on fasting insulin levels after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on plasma cytokine levels after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on plasma metabolomic and lipidomic profiles after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on blood transcriptomic profile after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Assessing the impact of intervention treatment on gut and salivary microbiome profile after 26 weeks of intervention
Tidsram: 26 weeks
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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.
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26 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ibrahim Janahi, MD, FCCP, FRCPCH, Chief Medical Officer
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SDR100071
- ARG01-0430-230037 (Annat bidrag/finansieringsnummer: Qatar Research Development and Innovation (QRDI))
Plan för individuella deltagardata (IPD)
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