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Ketogenic Diet and CPAP Previous Bariatric Surgery

NCT03791242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-06-25

No results posted yet for this study

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 standard technique for diagnosing OSAS and determining its severity \[2\]. The results of the examination provide the Apnea-Hypopnea Index \[AHI\], or the Respiratory Disturbance Index \[RDI\]), which will be used to quantify apnea and classify its severity based on an international score. In general, an AHI scoring less than 5 is considered "normal" (5-15 mild sleep apnea; \>15 moderate sleep apnea; ≥30 severe sleep apnea).

In order to improve those parameters in obese patients who have been diagnosed with OSAS and are candidates for BS (BS), national and international guidelines recommend preoperative CPAP (Continuous Positive Airway Pressure) treatment in order to reduce anaesthesia risks \[3-6\]. Furthermore, several studies report that obese OSAS patients benefit from preoperative weight loss \[1,7\] (in terms of AHI index, night snoring and arterial hypertension).

Obese patients who are candidates for BS often go on a preoperative diet in order to decrease weight and liver volume (especially of the left lobe) and correct any vitamin/mineral deficiency. The results of a recently published study show that 4 weeks of Ketogenic Micronutrient Enriched Diet (KMED) significantly reduce body weight, liver lobe volume and vitamin/mineral deficiencies in obese patients who prepare to undergo BS \[8\], with resulting foreseeable reduction of intraoperative complications and surgical time.

To date, there are no prospective multicenter randomized trials demonstrating whether a preoperative ketogenic diet associated with CPAP use improves OSAS versus treatment with CPAP alone, with the possibility of reducing the preoperative treatment period.

Aim of the study: To assess the clinical advantage in combining two preoperative strategies (CPAP + KMED) compared to preoperative treatment with CPAP alone, for the reduction of surgical risks in morbidly obese patients with severe OSAS who are scheduled for BS.

Conditions

  • Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery

Interventions

DEVICE

Cpap and ketogenic diet

Patients with severe OSAS who are BS candidates will be treated with CPAP only at night (Group 1), or CPAP at night + KMED daily (Group 2), for 4 weeks

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-03-19
Completion
2021-05-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791242 on ClinicalTrials.gov