Status:
COMPLETED
Ketogenic Diet and CPAP Previous Bariatric Surgery
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obstructive Sleep Apnea Syndrome (OSAS) and obesity tend to coexist and are often associated with arterial hypertension, dyslipidaemia, and insulin resistance \[1\]. Polysomnography (PSG) is the stand...
Detailed Description
A recent clinical study published in 2014 on the New England Journal of Medicine found that often even an initial modest body weight reduction can favourably modify apnea events and severity during th...
Eligibility Criteria
Inclusion
- BMI ≥35 Kg/m2
- Severe OSAS
- Non-smokers or who have quit smoking for at least 3 months
Exclusion
- kidney and/or liver conditions that would make a KMED diet unsuitable (creatinine levels \>1.8 mg/dL or liver enzyme levels (glutamic pyruvic transaminase \[GPT\] or glutamic oxaloacetic transaminase \[GOT\]) less than three times over the upper normal threshold
- psychological problems that would make CPAP treatment problematic
- BMI \> 60 Kg/m2
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03791242
Start Date
March 21 2019
End Date
May 19 2021
Last Update
June 25 2021
Active Locations (1)
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1
ICOT Hospital
Latina, Italy, 04100