NCT03530566

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

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Protein Supplies SL · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Obesity, Morbid
• Bariatric Surgery
• Comorbidity

Interventions

Type	Name	Description
OTHER	PnK® Method	A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
OTHER	standard diet	standard low calorie diet for weight loss

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2018-05-21
• Last updated: 2018-05-24