Bariatric Surgery, Comorbidity, Obesity, Morbid
Conditions
Keywords
PnK Method, obesity, very low calorie ketogenic diet, Comorbidity, Bariatric Surgery, weight loss
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).
Interventions
OTHERPnK® Method
A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
OTHERstandard diet
standard low calorie diet for weight loss
Sponsors
Protein Supplies SL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight loss at 3 monthes | from baseline to 3 monthes | Change in body weight from baseline to 3 monthes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight loss at 2 monthes | from baseline to 2 monthes | Change in body weight from baseline to 2 monthes |
| Body weight loss at 1 month | from baseline to 1 month | Change in body weight from baseline to 1 month |
| Change in systolic blood pressure at 3 monthes | from baseline to 3 monthes | Change in systolic blood pressure from baseline to 3 monthes |
| Change in diastolic blood pressure at 3 monthes | from baseline to 3 monthes | Change in diastolic blood pressure from baseline to 3 monthes |
| Change in systolic blood pressure at 2 monthes | from baseline to 2 monthes | Change in systolic blood pressure from baseline to 2 monthes |
| Change in diastolyc blood pressure at 2 monthes | from baseline to 2 monthes | Change in diastolyc blood pressure from baseline to 2 monthes |
| Change in systolic blood pressure at 1 month | from baseline to 1 month | Change in systolic blood pressure from baseline to 1 month |
| Change in diastolic blood pressure at 1 month | from baseline to 1 month | Change in diastolic blood pressure from baseline to 1 month |
| Change in blood glucose at 3 monthes | from baseline to 3 monthes | Change in blood glucose level from baseline to 3 monthes |
| Change in blood glucose at 2 monthes | from baseline to 2 monthes | Change in blood glucose level from baseline to 2 monthes |
| Change in blood glucose at 1 month | from baseline to 1 month | Change in blood glucose level from baseline to 1 month |
| Change in HbA1c at 3 monthes | from baseline to 3 monthes | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes |
| Change in HbA1c at 2 monthes | from baseline to 2 monthes | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes |
| Change in HbA1c at 1 month | from baseline to 1 month | Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month |
| Change in total cholesterol level at 3 monthes | from baseline to 3 monthes | Change in blood total cholesterol level from baseline to 3 monthes |
| Change in total cholesterol level at 2 monthes | from baseline to 2 monthes | Change in blood total cholesterol level from baseline to 2 monthes |
| Change in total cholesterol level at 1 month | from baseline to 1 month | Change in blood total cholesterol level from baseline to 1 months |
| Change in triglycerides level at 3 monthes | from baseline to 3 monthes | Change in blood triglycerides level from baseline to 3 monthes |
| Change in triglycerides level at 2 monthes | from baseline to 2 monthes | Change in blood triglycerides level from baseline to 2 monthes |
| Change in triglycerides level at 1 month | from baseline to 1 month | Change in blood triglycerides level from baseline to 1 month |
| Clinical Control of arterial hypertension at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical control of arterial hypertension at 3 months regarding baseline |
| Clinical Control of Hypercholesterolemia at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical control of Hypercholesterolemia at 3 months regarding baseline |
| Clinical Control of Hypertriglyceridemia at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical control of Hypertriglyceridemia at 3 months regarding baseline |
| Improvement of Sleep Apnea Obstructive Syndrome at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Sleep Apnea Obstructive Syndrome, regarding baseline. |
| Improvement of Chronic Respiratory Disease at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Chronic Respiratory Disease, regarding baseline. |
| Improvement of Obesity hypoventilation syndrome at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Obesity hypoventilation syndrome, regarding baseline. |
| Improvement of Metabolic syndrome at 3 months | from baseline to 3 monthes | 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. |
| Improvement of Atrial fibrillation at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Atrial fibrillation, regarding baseline. |
| Improvement of Cardiac insufficiency at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Cardiac insufficiency, regarding baseline. |
| Improvement of Pulmonary hypertension at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Pulmonary hypertension, regarding baseline. |
| Improvement of Cardiomyopathy at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of cardiomyopathy, regarding baseline. |
| Improvement of Renal insufficiency at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse clinical symptoms of Renal insufficiency, regarding baseline. |
| Obesity Surgery Mortality Risk Score | 3 months | Obesity Surgery Mortality Risk Score at the preoperative visit |
| Length of surgery | During bariatric surgery | Length (in minuts) of bariatric surgery |
| Length of anesthesia | During bariatric surgery | Length (in minuts) of anesthesia during bariatric surgery |
| Number of patients with intraoperative complications | During bariatric surgery | Number of patients with intraoperative complications occurring during bariatric surgery and within the postoperative 24 hours |
| Metabolic Control of type 2 Diabetes at 3 months | from baseline to 3 monthes | Percentage of patients with better, equal or worse metabolic control of type 2 Diabetes at 3 months regarding baseline |
| Number of total days of hospitalization | After bariatric surgery | Number of total days of hospitalization after bariatric surgery |
| Number of Participants With Adverse Events related to preoperative weight loss treatment | Through 3 months of study | Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PnK® Method) |
| Number of weight loss treatment dropout rate | from baseline to 3 monthes | Number of weight loss treatment dropout rate from baseline to 3 months |
| Number of patients who refuse bariatric surgery at 3 months | from baseline to 3 monthes | Number of patients who refuse bariatric surgery from baseline to 3 months |
| Number of patients with postoperative complications after bariatric surgery | After bariatric surgery | Number of patients with postoperative complications occurring before hospital discharge |
Contacts
Primary ContactGerman Guzman, Ph
Backup ContactMontse Vidal, Ph
Outcome results
None listed