Clinical trial
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Recruiting now · Not applicable · 1 countries · Registry ID NCT05364957
What this study is about
The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.
Basic eligibility
Full registry criteria
Treatments and study arms
Intragastric balloon device
Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
Dietary
The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
Exercise intervention
Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.
Primary outcomes
the proportion of patients with changed asthma control at 12 months , defined as a reduction in the Asthma Control Score (ACQ) ≥ 0.5, compared to baseline.
Study locations
1 locations were listed when this page was built. The first 40 are shown.