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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03530566
Other study ID # PRO-CBP-2017-02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2018
Est. completion date March 2019

Study information

Verified date May 2018
Source Protein Supplies SL
Contact German Guzman, Ph
Phone +34 674366358
Email German.G@pronokal.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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 information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date March 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
PnK® Method
A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
standard diet
standard low calorie diet for weight loss

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Protein Supplies SL

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight loss at 3 monthes Change in body weight from baseline to 3 monthes from baseline to 3 monthes
Secondary Body weight loss at 2 monthes Change in body weight from baseline to 2 monthes from baseline to 2 monthes
Secondary Body weight loss at 1 month Change in body weight from baseline to 1 month from baseline to 1 month
Secondary Change in systolic blood pressure at 3 monthes Change in systolic blood pressure from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in diastolic blood pressure at 3 monthes Change in diastolic blood pressure from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in systolic blood pressure at 2 monthes Change in systolic blood pressure from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in diastolyc blood pressure at 2 monthes Change in diastolyc blood pressure from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in systolic blood pressure at 1 month Change in systolic blood pressure from baseline to 1 month from baseline to 1 month
Secondary Change in diastolic blood pressure at 1 month Change in diastolic blood pressure from baseline to 1 month from baseline to 1 month
Secondary Change in blood glucose at 3 monthes Change in blood glucose level from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in blood glucose at 2 monthes Change in blood glucose level from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in blood glucose at 1 month Change in blood glucose level from baseline to 1 month from baseline to 1 month
Secondary Change in HbA1c at 3 monthes Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in HbA1c at 2 monthes Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in HbA1c at 1 month Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month from baseline to 1 month
Secondary Change in total cholesterol level at 3 monthes Change in blood total cholesterol level from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in total cholesterol level at 2 monthes Change in blood total cholesterol level from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in total cholesterol level at 1 month Change in blood total cholesterol level from baseline to 1 months from baseline to 1 month
Secondary Change in triglycerides level at 3 monthes Change in blood triglycerides level from baseline to 3 monthes from baseline to 3 monthes
Secondary Change in triglycerides level at 2 monthes Change in blood triglycerides level from baseline to 2 monthes from baseline to 2 monthes
Secondary Change in triglycerides level at 1 month Change in blood triglycerides level from baseline to 1 month from baseline to 1 month
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Obesity Surgery Mortality Risk Score Obesity Surgery Mortality Risk Score at the preoperative visit 3 months
Secondary Length of surgery Length (in minuts) of bariatric surgery During bariatric surgery
Secondary Length of anesthesia Length (in minuts) of anesthesia during bariatric surgery During bariatric surgery
Secondary 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
Secondary Number of patients with postoperative complications after bariatric surgery Number of patients with postoperative complications occurring before hospital discharge After bariatric surgery
Secondary Number of total days of hospitalization Number of total days of hospitalization after bariatric surgery After bariatric surgery
Secondary 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
Secondary Number of weight loss treatment dropout rate Number of weight loss treatment dropout rate from baseline to 3 months from baseline to 3 monthes
Secondary 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
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