Intragastric Balloon in Obese Patients With Uncontrolled Asthma
NCT ID: NCT05364957
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2023-05-12
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control (PEC dietary hygiene)
Diet and exercise alone (control)
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.
Experimental (BIG + PEC dietary hygiene)
Intragastric balloon combined with diet and exercise (active)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Asthma according to the Global Initiative for Asthma (GINA) criteria
3. Patients with uncontrolled asthma based on an ACQ score ≥1.5 despite inhaled corticosteroids ± long acting bronchodilators (LABA)
4. Patients with grade I obesity (BMI\> 30 kg/m² and \< 35 kg/m²) or morbid obesity (BMI\<40 or ≥35 kg/m² with serious physiological risks, as recommended by the French Health Authorities) with contraindications for or refusal of bariatric surgery.
5. Effective contraception for women
6. Patients who have signed a written informed consent form
7. Patients with health insurance
8. Complete COVID-19 vaccination schedule according to current guidelines
Exclusion Criteria
2. Blood eosinophilia greater than 4.5 G/I
3. Treatment by biotherapy within the 12 months after inclusion
4. Cancer diagnosed within the last 5 years
5. Smoking \> 10 packs/year (PA)
6. One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement.
7. Treatment with orlistat Xénical® or GLP1 analogues or regular consumption of narcotics (heroin, cocaine and amphetamines). Analgesic treatments, including level 3, are authorized during the study.
8. Any patient for whom IGB is contraindicated \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]:
8.1 Severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction 8.2 Severe and unstabilised eating disorders: bulimia or history of anorexia 8.3 History of gastric surgery including the ring insertion 8.4 Haemostasis disorders 8.5 Anticoagulant or non-steroidal anti-inflammatory medicines 8.6 Severe liver disease 8.7 Pregnancy or desire to become pregnant or breastfeeding 8.8 Anticipated failure to comply with prolonged medical follow-up 8.9 Large hiatal hernias \> 5 cm, inflammatory (Crohn's) or stenosing small bowel disease, pyloric stenosis and structural abnormalities of the digestive tract 8.10 Systemic lupus erythematous 8.11 Severe oesophagitis and active gastroduodenal ulcer 8.12 Silicone allergy
9. Patient under guardianship or tutorship, persons placed under the protection of justice or persons participating in another search including an exclusion period still in progress
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Guilleminault M Laurent, MD
Role: PRINCIPAL_INVESTIGATOR
Study principal Investigator Toulouse University Hospital
Locations
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University Hospital Toulouse
Toulouse, Occitanie, France
Countries
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Central Contacts
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Other Identifiers
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2019-A00595-52
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/18/0473
Identifier Type: -
Identifier Source: org_study_id