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

Protein Supplies SL

Status: Unknown

Conditions: Bariatric Surgery; Obesity, Morbid; Comorbidity

Treatments: Other: standard diet; Other: PnK® Method

Study type: Observational

Funder types: Other

Identifiers

NCT03530566

PRO-CBP-2017-02

Details and patient eligibility

About

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

Full 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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes, between 18 and 65 years old
• Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities associated with obesity (type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea, obesity hypoventilation syndrome, chronic respiratory disease, metabolic syndrome, atrial fibrillation, heart failure, pulmonary hypertension, cardiomyopathy, history of thrombosis, renal failure).
• Patients scheduled for bariatric surgery within 3 months ± 1 week.
• Patients who, regardless of their inclusion in this study, will undergo treatment with the multidisciplinary slimming program in study or standard diet.
• Patients who agree to participate and sign the Informed Consent

Exclusion criteria

• Pregnant or lactating women.
• Patients with type 1 diabetes mellitus or on insulin therapy
• Patients with eating disorders, alcoholism, and/or drug addiction.
• Patients with any severe psychological disorder (eg schizophrenia, bipolar disorder).
• Patients receiving dicumarinic anticoagulants (Sintrom®) or cortisone.
• Patients with liver failure.
• Patients with severe kidney failure (gfr <30).
• Patients with hemopathies.
• Patients with cancer.
• Patients with cardiovascular or cerebrovascular disease (heart rate disorders, recent infarction [<6m], unstable angina, decompensated heart failure, recent stroke [<6m]).
• Patients in acute attack of gout.
• Patients with renal lithiasis verified by ultrasound.
• Patients with cholelithiasis verified by ultrasound.
• Patients with depression.
• Patients with electrolyte imbalance, according to medical criteria.
• Patients with orthostatic hypotension.
• Patients with contraindications to surgery

Trial design

25 participants in 2 patient groups

Pnk group

Description:

Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities, scheduled bariatric surgery within 3 months will be treated with PnK® Method

Treatment:

Other: PnK® Method

Control group

Description:

Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities, treated with standard diet 3 moths prior bariatric surgery

Treatment:

Other: standard diet