Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
- Conditions
- Bariatric SurgeryComorbidityObesity, Morbid
- Interventions
- Other: PnK® MethodOther: standard diet
- Registration Number
- NCT03530566
- Lead Sponsor
- Protein Supplies SL
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pnk group PnK® Method 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 Control group standard diet 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
- Primary Outcome Measures
Name Time Method Body weight loss at 3 monthes from baseline to 3 monthes Change in body weight from baseline to 3 monthes
- Secondary Outcome Measures
Name Time Method 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 1 month from baseline to 1 month Change in blood total cholesterol level from baseline to 1 months
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 diastolyc blood pressure at 2 monthes from baseline to 2 monthes Change in diastolyc blood pressure from baseline to 2 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 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 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 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
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
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.
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
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.
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
Number of patients with postoperative complications after bariatric surgery After bariatric surgery Number of patients with postoperative complications occurring before hospital discharge
Number of total days of hospitalization After bariatric surgery Number of total days of hospitalization after bariatric surgery
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
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