Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title: Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery

Status Not yet recruiting

Clinical Trial Summary

Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.

Clinical Trial Description

Study population: 25 patients with morbid obesity (BMI ≥ 40 kg / m2) or severe obesity (BMI 35 to 39.9 kg / m2) , with two or more comorbidities, scheduled for bariatric surgery within 3 months, and who will start treatment with the multidisciplinary weight loss program (PnK Method) based on diet, exercise and psychological support.

Patients will be followed-up for 3 months, with the following controls: pre-selection, baseline, month 1, month 2, month 3, and control when hospital discharge.

The treatment schedule in these patients will be as follows: a very low calorie ketogenic diet for at least 1 month or until losing 10% of the weight, and then, a low calorie diet with gradual reintroduction of natural foods for 2 months, until surgery.

The investigators will obtain retrospective data from 25 patients treated with the standard diet who met the same inclusion/exclusion criteria as the patients in this study and who similarly resemble in age, sex and BMI, for comparative analysis (control group). ;

Related Conditions & MeSH terms

• Bariatric Surgery
• Comorbidity
• Obesity, Morbid
• Weight Loss

• NCT number: NCT03530566
• Study type: Observational [Patient Registry]
• Source: Protein Supplies SL
• Contact: German Guzman, Ph
• Phone: +34 674366358
• Email: German.G@pronokal.com
• Status: Not yet recruiting
• Start date: May 2018
• Completion date: March 2019