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Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.
Study population: 25 patients with morbid obesity (BMI ā„ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pnk group | Patients with morbid obesity (BMI ā„ 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 PnKĀ® Method |
| |
| Control group | Patients with morbid obesity (BMI ā„ 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PnKĀ® Method | Other | A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight loss at 3 monthes | Change in body weight from baseline to 3 monthes | from baseline to 3 monthes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with morbid obesity (BMI ā„ 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| German Guzman, Ph | Contact | +34 674366358 | German.G@pronokal.com | |
| Montse Vidal, Ph | Contact | +34 663825890 | montsevidal@crossdata.es |
| Name | Affiliation | Role |
|---|---|---|
| Davide De Carvalho, Ph | Centro Hospitalar Sao Joao do Porto | Principal Investigator |
| Paula Freitas, Ph | Centro Hospitalar Sao Joao do Porto | Principal Investigator |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| standard diet | Other | standard low calorie diet for weight loss |
|
| 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 (PnKĀ® 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |