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

NCT03530566 | Unknown

• 1 other identifier: PRO-CBP-2017-02
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity, Morbid; Bariatric Surgery; Comorbidity

Keywords

PnK Method; obesity; very low calorie ketogenic diet; Comorbidity; Bariatric Surgery; weight loss

Outcome Measures

Primary Outcomes (1)

• Body weight loss at 3 monthes

  Change in body weight from baseline to 3 monthes

  from baseline to 3 monthes

Secondary Outcomes (42)

• Body weight loss at 2 monthes

  from baseline to 2 monthes

• Body weight loss at 1 month

  from baseline to 1 month

• Change in systolic blood pressure at 3 monthes

  from baseline to 3 monthes

• Change in diastolic blood pressure at 3 monthes

  from baseline to 3 monthes

• Change in systolic blood pressure at 2 monthes

  from baseline to 2 monthes

Study Arms (2)

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

Other: PnK® Method

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

Other: standard diet

Interventions

PnK® Method OTHER

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

Pnk group

standard diet OTHER

standard low calorie diet for weight loss

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 to undergo bariatric surgery within 3 months, should be treated with the multidisciplinary weight loss program in study.

You may qualify if:

• 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 agree to participate and sign the Informed Consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protein Supplies SL: lead

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Davide De Carvalho, Ph

  Centro Hospitalar Sao Joao do Porto

  PRINCIPAL INVESTIGATOR

• Paula Freitas, Ph

  Centro Hospitalar Sao Joao do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

German Guzman, Ph

CONTACT

+34 674366358; German.G@pronokal.com

Montse Vidal, Ph

CONTACT

+34 663825890; montsevidal@crossdata.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 24, 2018

Record last verified: 2018-05