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

NCT ID: NCT03530566

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2019-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pnk group

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

PnK® Method

Intervention Type: OTHER

A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support

Control group

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

standard diet

Intervention Type: OTHER

standard low calorie diet for weight loss

Interventions

PnK® Method

A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support

Intervention Type: OTHER

standard diet

standard low calorie diet for weight loss

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Protein Supplies SL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide De Carvalho, Ph

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Sao Joao do Porto

Paula Freitas, Ph

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Sao Joao do Porto

Central Contacts

German Guzman, Ph

Role: CONTACT

German.G@pronokal.com

+34 674366358

Montse Vidal, Ph

Role: CONTACT

montsevidal@crossdata.es

+34 663825890

Other Identifiers

PRO-CBP-2017-02

Identifier Type: -

Identifier Source: org_study_id