Clinical trial NCT03857191: Nutritional Rehabilitation and Sleep Apnea in the Obese
Official title: Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Sleep Apnea, Obstructive
Keywords: obesity
sleep apnea
hypertension
type 2 diabetes
CPAP
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Groupe Éthique et Santé
First posted: 2019-02-27
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese patients

Brief summary: In obese patients, the prevalence of obstructive sleep apnea (OSA) is around 40% in men and 30% in women. Weight loss after bariatric surgery significantly improves OSA, with 75% of patients having a reduction in OSA severity or becoming non-apneic. We hypothesize a similar effect on OSA of nutritional and psychocomportemental rehabilitation for obese patients. However, we expect weight loss and blood pressure reduction to probably be lower in obese patients who have OSA and nutritional rehabilitation alone than in those who are treated for their OSA or are without OSA. To address this question, we will conduct an observational study on obese patients, treated or not for OSA, following nutritional and psychocomportemental rehabilitation.

Detailed description: In obese patients, OSA prevalence is around 40% in men and 30% in women. Being overweight or obese are independent risk factors for OSA, and the prevalence increases with body mass index (BMI). Weight loss after bariatric surgery is one treatment for OSA, 75% of patients having a reduction in OSA severity or becoming non-apneic. OSA and obesity both induce type 2 diabetes, hypertension and/or nonalcoholic fatty liver disease (NAFLD). A randomized study (Chirinos et al. NEJM 2014) demonstrated a better improvement in blood pressure, triglyceride levels or insulin resistance with weight loss alone or weight loss associated with continuous positive airway pressure (CPAP) than with CPAP alone. We hypothesize a similar effect of nutritional and psychocomportemental rehabilitation on OSA. However, weight loss and blood pressure improvements could be lesser in untreated OSA patients than in treated OSA or non-OSA patients. It has been demonstrated that bariatric surgery reduces medication use such as antihypertensive or antidiabetic drugs, and thus a secondary objective is to determine whether nutritional and psychocomportemental rehabilitation similarly reduces medication use by the overweight and obese.

Eligibility criteria: Inclusion Criteria:

* BMI \> 25 kg/m² and/or waist circumference \> 80 cm in women or 94 cm in men
* Patients registered to follow a nutritional psychocomportemental reeducation program with the "Ethique et Santé" group

Exclusion Criteria:

- Subjects covered by articles L1121-5 to L1121-8 of French law

Primary outcomes:
measure: Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation
timeFrame: 25 weeks
Secondary outcomes:
measure: Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation
timeFrame: 25 weeks
measure: Weight loss according to OSA status
timeFrame: 25 weeks
measure: Change in Blood pressure according to OSA status
timeFrame: 25 weeks
measure: Change in Medication use according to OSA status
timeFrame: 25 weeks
measure: To assess the effect of Weight loss on OSA
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: