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

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

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

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid; Bariatric Surgery; Comorbidity
• Intervention / Treatment: Other: PnK® Method; Other: standard diet

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).

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 to undergo bariatric surgery within 3 months, should be treated with the multidisciplinary weight loss program in study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pnk group; 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; A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
Control group; 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; standard low calorie diet for weight loss

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Protein Supplies SL
• Investigators: Principal Investigator: Davide De Carvalho, Ph, Centro Hospitalar Sao Joao do Porto; Principal Investigator: Paula Freitas, Ph, Centro Hospitalar Sao Joao do Porto

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: obesity; weight loss; Bariatric Surgery; Comorbidity; PnK Method; very low calorie ketogenic diet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: PRO-CBP-2017-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No