Obesity, MorbidNCT03530566
Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
An observational study of Obesity, Morbid and Bariatric Surgery, run by Protein Supplies SL.
Trial summary
Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery, Comorbidity
- What is being tested?
- PnK® Method and standard diet
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Mar 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.
Read the 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).
- Conditions
- Obesity, Morbid, Bariatric Surgery, Comorbidity
- Being tested
- PnK® Method, standard diet
- Keywords
- PnK Method, obesity, very low calorie ketogenic diet, Comorbidity, Bariatric Surgery, weight loss
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PnK® MethodOther
A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
standard dietOther
standard low calorie diet for weight loss
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PnK® Method | |
| 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 Receives: Other: standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight loss at 3 monthes
Change in body weight from baseline to 3 monthes
Measured: from baseline to 3 monthes
Secondary outcomes (42)
Body weight loss at 2 monthes
Change in body weight from baseline to 2 monthes
Measured: from baseline to 2 monthes
Body weight loss at 1 month
Change in body weight from baseline to 1 month
Measured: from baseline to 1 month
Change in systolic blood pressure at 3 monthes
Change in systolic blood pressure from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in diastolic blood pressure at 3 monthes
Change in diastolic blood pressure from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in systolic blood pressure at 2 monthes
Change in systolic blood pressure from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in diastolyc blood pressure at 2 monthes
Change in diastolyc blood pressure from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in systolic blood pressure at 1 month
Change in systolic blood pressure from baseline to 1 month
Measured: from baseline to 1 month
Change in diastolic blood pressure at 1 month
Change in diastolic blood pressure from baseline to 1 month
Measured: from baseline to 1 month
Change in blood glucose at 3 monthes
Change in blood glucose level from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in blood glucose at 2 monthes
Change in blood glucose level from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in blood glucose at 1 month
Change in blood glucose level from baseline to 1 month
Measured: from baseline to 1 month
Change in HbA1c at 3 monthes
Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in HbA1c at 2 monthes
Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in HbA1c at 1 month
Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month
Measured: from baseline to 1 month
Change in total cholesterol level at 3 monthes
Change in blood total cholesterol level from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in total cholesterol level at 2 monthes
Change in blood total cholesterol level from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in total cholesterol level at 1 month
Change in blood total cholesterol level from baseline to 1 months
Measured: from baseline to 1 month
Change in triglycerides level at 3 monthes
Change in blood triglycerides level from baseline to 3 monthes
Measured: from baseline to 3 monthes
Change in triglycerides level at 2 monthes
Change in blood triglycerides level from baseline to 2 monthes
Measured: from baseline to 2 monthes
Change in triglycerides level at 1 month
Change in blood triglycerides level from baseline to 1 month
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from baseline to 3 monthes
Obesity Surgery Mortality Risk Score
Obesity Surgery Mortality Risk Score at the preoperative visit
Measured: 3 months
Length of surgery
Length (in minuts) of bariatric surgery
Measured: During bariatric surgery
Length of anesthesia
Length (in minuts) of anesthesia during bariatric surgery
Measured: 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
Measured: During bariatric surgery
Number of patients with postoperative complications after bariatric surgery
Number of patients with postoperative complications occurring before hospital discharge
Measured: After bariatric surgery
Number of total days of hospitalization
Number of total days of hospitalization after bariatric surgery
Measured: 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)
Measured: Through 3 months of study
Number of weight loss treatment dropout rate
Number of weight loss treatment dropout rate from baseline to 3 months
Measured: 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
Measured: from baseline to 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startMay 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Protein Supplies SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide De Carvalho, Ph, Principal investigator, Centro Hospitalar Sao Joao do PortoPaula Freitas, Ph, Principal investigator, Centro Hospitalar Sao Joao do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530566
- Sponsor's protocol ID
- PRO-CBP-2017-02
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03530566
- Acronym / sponsor ID
- PRO-CBP-2017-02
- Conditions
- Obesity, Morbid, Bariatric Surgery, Comorbidity
- Keywords
- PnK Method, obesity, very low calorie ketogenic diet, Comorbidity, Bariatric Surgery, weight loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Protein Supplies SLUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pnk group | – | Other: PnK® MethodPatients 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 | – | Other: standard dietPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PnK® MethodA multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support | Other | Pnk group |
| standard dietstandard low calorie diet for weight loss | Other | Control group |
Primary outcome
Body weight loss at 3 monthes
Time frame: from baseline to 3 monthes
Change in body weight from baseline to 3 monthes
42 secondary outcomes
Body weight loss at 2 monthes
Time frame: from baseline to 2 monthes
Body weight loss at 1 month
Time frame: from baseline to 1 month
Change in systolic blood pressure at 3 monthes
Time frame: from baseline to 3 monthes
Change in diastolic blood pressure at 3 monthes
Time frame: from baseline to 3 monthes
Change in systolic blood pressure at 2 monthes
Time frame: from baseline to 2 monthes
Change in diastolyc blood pressure at 2 monthes
Time frame: from baseline to 2 monthes
Change in systolic blood pressure at 1 month
Time frame: from baseline to 1 month
Change in diastolic blood pressure at 1 month
Time frame: from baseline to 1 month
Change in blood glucose at 3 monthes
Time frame: from baseline to 3 monthes
Change in blood glucose at 2 monthes
Time frame: from baseline to 2 monthes
Change in blood glucose at 1 month
Time frame: from baseline to 1 month
Change in HbA1c at 3 monthes
Time frame: from baseline to 3 monthes
Change in HbA1c at 2 monthes
Time frame: from baseline to 2 monthes
Change in HbA1c at 1 month
Time frame: from baseline to 1 month
Change in total cholesterol level at 3 monthes
Time frame: from baseline to 3 monthes
Change in total cholesterol level at 2 monthes
Time frame: from baseline to 2 monthes
Change in total cholesterol level at 1 month
Time frame: from baseline to 1 month
Change in triglycerides level at 3 monthes
Time frame: from baseline to 3 monthes
Change in triglycerides level at 2 monthes
Time frame: from baseline to 2 monthes
Change in triglycerides level at 1 month
Time frame: from baseline to 1 month
Metabolic Control of type 2 Diabetes at 3 months
Time frame: from baseline to 3 monthes
Clinical Control of arterial hypertension at 3 months
Time frame: from baseline to 3 monthes
Clinical Control of Hypercholesterolemia at 3 months
Time frame: from baseline to 3 monthes
Clinical Control of Hypertriglyceridemia at 3 months
Time frame: from baseline to 3 monthes
Improvement of Sleep Apnea Obstructive Syndrome at 3 months
Time frame: from baseline to 3 monthes
Improvement of Chronic Respiratory Disease at 3 months
Time frame: from baseline to 3 monthes
Improvement of Obesity hypoventilation syndrome at 3 months
Time frame: from baseline to 3 monthes
Improvement of Metabolic syndrome at 3 months
Time frame: from baseline to 3 monthes
Improvement of Atrial fibrillation at 3 months
Time frame: from baseline to 3 monthes
Improvement of Cardiac insufficiency at 3 months
Time frame: from baseline to 3 monthes
Improvement of Pulmonary hypertension at 3 months
Time frame: from baseline to 3 monthes
Improvement of Cardiomyopathy at 3 months
Time frame: from baseline to 3 monthes
Improvement of Renal insufficiency at 3 months
Time frame: from baseline to 3 monthes
Obesity Surgery Mortality Risk Score
Time frame: 3 months
Length of surgery
Time frame: During bariatric surgery
Length of anesthesia
Time frame: During bariatric surgery
Number of patients with intraoperative complications
Time frame: During bariatric surgery
Number of patients with postoperative complications after bariatric surgery
Time frame: After bariatric surgery
Number of total days of hospitalization
Time frame: After bariatric surgery
Number of Participants With Adverse Events related to preoperative weight loss treatment
Time frame: Through 3 months of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide De Carvalho, Ph principal investigator
Centro Hospitalar Sao Joao do Porto
Paula Freitas, Ph principal investigator
Centro Hospitalar Sao Joao do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Bariatric Surgery, run by Protein Supplies SL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact German Guzman, Ph (+34 674366358, German.G@pronokal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight loss at 3 monthes (time frame: from baseline to 3 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.