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

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

Detailed Description
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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).

Official Title
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Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery

Conditions
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Obesity, Morbid, Bariatric Surgery, Comorbidity

Intervention / Treatment
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* Other: PnK® Method
* Other: standard diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pnk group<br>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<br>* A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support<br>|
| Control group<br>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<br>* standard low calorie diet for weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight loss at 3 monthes | Change in body weight from baseline to 3 monthes | from baseline to 3 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight loss at 2 monthes | Change in body weight from baseline to 2 monthes | from baseline to 2 monthes | 
| Body weight loss at 1 month | Change in body weight from baseline to 1 month | from baseline to 1 month | 
| Change in systolic blood pressure at 3 monthes | Change in systolic blood pressure from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in diastolic blood pressure at 3 monthes | Change in diastolic blood pressure from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in systolic blood pressure at 2 monthes | Change in systolic blood pressure from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in diastolyc blood pressure at 2 monthes | Change in diastolyc blood pressure from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in systolic blood pressure at 1 month | Change in systolic blood pressure from baseline to 1 month | from baseline to 1 month | 
| Change in diastolic blood pressure at 1 month | Change in diastolic blood pressure from baseline to 1 month | from baseline to 1 month | 
| Change in blood glucose at 3 monthes | Change in blood glucose level from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in blood glucose at 2 monthes | Change in blood glucose level from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in blood glucose at 1 month | Change in blood glucose level from baseline to 1 month | from baseline to 1 month | 
| Change in HbA1c at 3 monthes | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in HbA1c at 2 monthes | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in HbA1c at 1 month | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month | from baseline to 1 month | 
| Change in total cholesterol level at 3 monthes | Change in blood total cholesterol level from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in total cholesterol level at 2 monthes | Change in blood total cholesterol level from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in total cholesterol level at 1 month | Change in blood total cholesterol level from baseline to 1 months | from baseline to 1 month | 
| Change in triglycerides level at 3 monthes | Change in blood triglycerides level from baseline to 3 monthes | from baseline to 3 monthes | 
| Change in triglycerides level at 2 monthes | Change in blood triglycerides level from baseline to 2 monthes | from baseline to 2 monthes | 
| Change in triglycerides level at 1 month | Change in blood triglycerides level from baseline to 1 month | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | from baseline to 3 monthes | 
| Obesity Surgery Mortality Risk Score | Obesity Surgery Mortality Risk Score at the preoperative visit | 3 months | 
| Length of surgery | Length (in minuts) of bariatric surgery | During bariatric surgery | 
| Length of anesthesia | Length (in minuts) of anesthesia during bariatric surgery | 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 | During bariatric surgery | 
| Number of patients with postoperative complications after bariatric surgery | Number of patients with postoperative complications occurring before hospital discharge | After bariatric surgery | 
| Number of total days of hospitalization | Number of total days of hospitalization after bariatric surgery | 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) | Through 3 months of study | 
| Number of weight loss treatment dropout rate | Number of weight loss treatment dropout rate from baseline to 3 months | 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 | from baseline to 3 monthes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PnK Method, obesity, very low calorie ketogenic diet, Comorbidity, Bariatric Surgery, weight loss