NCT03791242

Ketogenic Diet and CPAP Previous Bariatric Surgery

Completed NA Last updated 25 June 2021

What this trial tests

NA trial testing Cpap and ketogenic diet in Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery in 66 participants. Completed in 19 May 2021.

Timeline

21 March 2019

Primary endpoint
19 March 2021

19 May 2021

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	66
Start date	21 March 2019
Primary completion	19 March 2021
Estimated completion	19 May 2021
Sites	1 location across Italy

Drugs / interventions tested

• Cpap and ketogenic diet

Conditions studied

• Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery — all drugs for Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery →

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 65, any sex, with Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Low-Calorie Ketogenic Diet with Continuous Positive Airway Pressure to Alleviate Severe Obstructive Sleep Apnea Syndrome in Patients with Obesity Scheduled for Bariatric/Metabolic Surgery: a Pilot, Prospective, Randomized Multicenter Comparative Study.
   Schiavo L, Pierro R, Asteria C, Calabrese P, et al · · 2022 · cited 34× · PMID 34802065 · DOI 10.1007/s11695-021-05811-1