Clinical trial NCT03530566: Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Official title: Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Morbid
Bariatric Surgery
Comorbidity
Keywords: PnK Method
obesity
very low calorie ketogenic diet
Comorbidity
Bariatric Surgery
weight loss
Lead sponsor: Protein Supplies SL
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Body weight loss at 3 monthes
timeFrame: from baseline to 3 monthes
Secondary outcomes:
measure: Body weight loss at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Body weight loss at 1 month
timeFrame: from baseline to 1 month
measure: Change in systolic blood pressure at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in diastolic blood pressure at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in systolic blood pressure at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in diastolyc blood pressure at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in systolic blood pressure at 1 month
timeFrame: from baseline to 1 month
measure: Change in diastolic blood pressure at 1 month
timeFrame: from baseline to 1 month
measure: Change in blood glucose at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in blood glucose at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in blood glucose at 1 month
timeFrame: from baseline to 1 month
measure: Change in HbA1c at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in HbA1c at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in HbA1c at 1 month
timeFrame: from baseline to 1 month
measure: Change in total cholesterol level at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in total cholesterol level at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in total cholesterol level at 1 month
timeFrame: from baseline to 1 month
measure: Change in triglycerides level at 3 monthes
timeFrame: from baseline to 3 monthes
measure: Change in triglycerides level at 2 monthes
timeFrame: from baseline to 2 monthes
measure: Change in triglycerides level at 1 month
timeFrame: from baseline to 1 month
measure: Metabolic Control of type 2 Diabetes at 3 months
timeFrame: from baseline to 3 monthes
measure: Clinical Control of arterial hypertension at 3 months
timeFrame: from baseline to 3 monthes
measure: Clinical Control of Hypercholesterolemia at 3 months
timeFrame: from baseline to 3 monthes
measure: Clinical Control of Hypertriglyceridemia at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Sleep Apnea Obstructive Syndrome at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Chronic Respiratory Disease at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Obesity hypoventilation syndrome at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Metabolic syndrome at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Atrial fibrillation at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Cardiac insufficiency at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Pulmonary hypertension at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Cardiomyopathy at 3 months
timeFrame: from baseline to 3 monthes
measure: Improvement of Renal insufficiency at 3 months
timeFrame: from baseline to 3 monthes
measure: Obesity Surgery Mortality Risk Score
timeFrame: 3 months
measure: Length of surgery
timeFrame: During bariatric surgery
measure: Length of anesthesia
timeFrame: During bariatric surgery
measure: Number of patients with intraoperative complications
timeFrame: During bariatric surgery
measure: Number of patients with postoperative complications after bariatric surgery
timeFrame: After bariatric surgery
measure: Number of total days of hospitalization
timeFrame: After bariatric surgery
measure: Number of Participants With Adverse Events related to preoperative weight loss treatment
timeFrame: Through 3 months of study
measure: Number of weight loss treatment dropout rate
timeFrame: from baseline to 3 monthes
measure: Number of patients who refuse bariatric surgery at 3 months
timeFrame: from baseline to 3 monthes
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar Sao Joao do Porto
name: Davide De Carvalho, Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar Sao Joao do Porto
name: Paula Freitas, Ph
role: PRINCIPAL_INVESTIGATOR
References: