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

Protein Supplies SL25 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity, Morbid Bariatric Surgery Comorbidity

Interventions

PnK® MethodOTHER

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

standard dietOTHER

standard low calorie diet for weight loss

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Body weight loss at 3 monthes

Change in body weight from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Secondary Outcomes

Body weight loss at 2 monthes

Change in body weight from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Body weight loss at 1 month

Change in body weight from baseline to 1 month

Time frame: from baseline to 1 month

Change in systolic blood pressure at 3 monthes

Change in systolic blood pressure from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in diastolic blood pressure at 3 monthes

Change in diastolic blood pressure from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in systolic blood pressure at 2 monthes

Change in systolic blood pressure from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in diastolyc blood pressure at 2 monthes

Change in diastolyc blood pressure from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in systolic blood pressure at 1 month

Change in systolic blood pressure from baseline to 1 month

Time frame: from baseline to 1 month

Central Contacts

German Guzman, Ph

CONTACT

+34 674366358 German.G@pronokal.com

Montse Vidal, Ph

CONTACT

+34 663825890 montsevidal@crossdata.es

Data from ClinicalTrials.gov

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Change in diastolic blood pressure at 1 month

Change in diastolic blood pressure from baseline to 1 month

Time frame: from baseline to 1 month

Change in blood glucose at 3 monthes

Change in blood glucose level from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in blood glucose at 2 monthes

Change in blood glucose level from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in blood glucose at 1 month

Change in blood glucose level from baseline to 1 month

Time frame: from baseline to 1 month

Change in HbA1c at 3 monthes

Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in HbA1c at 2 monthes

Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in HbA1c at 1 month

Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month

Time frame: from baseline to 1 month

Change in total cholesterol level at 3 monthes

Change in blood total cholesterol level from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in total cholesterol level at 2 monthes

Change in blood total cholesterol level from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in total cholesterol level at 1 month

Change in blood total cholesterol level from baseline to 1 months

Time frame: from baseline to 1 month

Change in triglycerides level at 3 monthes

Change in blood triglycerides level from baseline to 3 monthes

Time frame: from baseline to 3 monthes

Change in triglycerides level at 2 monthes

Change in blood triglycerides level from baseline to 2 monthes

Time frame: from baseline to 2 monthes

Change in triglycerides level at 1 month

Change in blood triglycerides level from baseline to 1 month

Time frame: from baseline to 1 month

Metabolic Control of type 2 Diabetes at 3 months

Percentage of patients with better, equal or worse metabolic control of type 2 Diabetes at 3 months regarding baseline

Time frame: from baseline to 3 monthes

Clinical Control of arterial hypertension at 3 months

Percentage of patients with better, equal or worse clinical control of arterial hypertension at 3 months regarding baseline

Time frame: from baseline to 3 monthes

Clinical Control of Hypercholesterolemia at 3 months

Percentage of patients with better, equal or worse clinical control of Hypercholesterolemia at 3 months regarding baseline

Time frame: from baseline to 3 monthes

Clinical Control of Hypertriglyceridemia at 3 months

Percentage of patients with better, equal or worse clinical control of Hypertriglyceridemia at 3 months regarding baseline

Time frame: from baseline to 3 monthes

Improvement of Sleep Apnea Obstructive Syndrome at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Sleep Apnea Obstructive Syndrome, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Chronic Respiratory Disease at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Chronic Respiratory Disease, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Obesity hypoventilation syndrome at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Obesity hypoventilation syndrome, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Metabolic syndrome at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Percentage of patients with better, equal or worse clinical symptoms of Obesity hypoventilation syndrome, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Atrial fibrillation at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Atrial fibrillation, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Cardiac insufficiency at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Cardiac insufficiency, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Pulmonary hypertension at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Pulmonary hypertension, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Cardiomyopathy at 3 months

Percentage of patients with better, equal or worse clinical symptoms of cardiomyopathy, regarding baseline.

Time frame: from baseline to 3 monthes

Improvement of Renal insufficiency at 3 months

Percentage of patients with better, equal or worse clinical symptoms of Renal insufficiency, regarding baseline.

Time frame: from baseline to 3 monthes

Obesity Surgery Mortality Risk Score

Obesity Surgery Mortality Risk Score at the preoperative visit

Time frame: 3 months

Length of surgery

Length (in minuts) of bariatric surgery

Time frame: During bariatric surgery

Length of anesthesia

Length (in minuts) of anesthesia during bariatric surgery

Time frame: During bariatric surgery

Number of patients with intraoperative complications

Number of patients with intraoperative complications occurring during bariatric surgery and within the postoperative 24 hours

Time frame: During bariatric surgery

Number of patients with postoperative complications after bariatric surgery

Number of patients with postoperative complications occurring before hospital discharge

Time frame: After bariatric surgery

Number of total days of hospitalization

Number of total days of hospitalization after bariatric surgery

Time frame: After bariatric surgery

Number of Participants With Adverse Events related to preoperative weight loss treatment

Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PnK® Method)

Time frame: Through 3 months of study

Number of weight loss treatment dropout rate

Number of weight loss treatment dropout rate from baseline to 3 months

Time frame: from baseline to 3 monthes

Number of patients who refuse bariatric surgery at 3 months

Number of patients who refuse bariatric surgery from baseline to 3 months

Time frame: from baseline to 3 monthes