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.
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Ibrahim Janahi, MD, FCCP, FRCPCH
- 전화번호: 00974 40032201
- 이메일: ijanahi@sidra.org
연구 연락처 백업
- 이름: Ibrahim Janahi
연구 장소
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Qa
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Doha, Qa, 카타르, 26999
- Sidra Medicine
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연락하다:
- Ibrahim Janahi
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연락하다:
- Ibrahim Janahi, MD, FCCP, FRCPCH
- 전화번호: 40037684
- 이메일: IJanahi@sidra.org
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ibrahim Janahi, MD, FCCP, FRCPCH, Chief Medical Officer
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SDR100071
- ARG01-0430-230037 (기타 보조금/기금 번호: Qatar Research Development and Innovation (QRDI))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Obesity-associated Asthma에 대한 임상 시험
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The Royal Wolverhampton Hospitals NHS Trust완전한말기 신장 질환(ESRD) | 만성 신장 질환(CKD) | 급성 신장 손상(AKI) | 예상 사구체 여과율(eGFR) | NGAL(Neutrophil Gelatinase-associated Lipocalin) | 혈청 크레아티닌(SCr) | 소변 크레아티닌(UCr) | 소변 알부민(Ulb)영국
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LMU KlinikumSeventh Framework Programme; NBIA Alliance모병뇌 철 축적을 동반한 신경변성(NBIA) | 판토텐산 키나제 관련 신경변성(PKAN) | 아세룰로플라스민혈증 | 베타-프로펠러 단백질 관련 신경변성(BPAN) | 미토콘드리아 막 단백질 관련 신경변성(MPAN) | 지방산 수산화효소 관련 신경변성(FAHN) | 쿠포 라켑 증후군 | 신경페리티노병증 | 우드하우스 사카티 증후군 | COASY 단백질 관련 신경변성(CoPAN) | PLA2G6 관련 신경변성(PLAN)캐나다, 체코, 독일, 이탈리아, 네덜란드, 폴란드, 세르비아, 스페인
Metfomin에 대한 임상 시험
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The University of Hong Kong아직 모집하지 않음
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Uruk University완전한
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Erbil Polytechnic UniversityKurdistan Higher Council of Medical Specialties완전한제2형 당뇨병 | 비만 당뇨병 환자 | 비만 환자(BMI ≥ 30 kg/m²)이라크