Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT03530566
Status:
UNKNOWN
Last Update Posted:
2018-05-24
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight loss at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in body weight from baseline to 3 monthes'}], 'secondaryOutcomes': [{'measure': 'Body weight loss at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in body weight from baseline to 2 monthes'}, {'measure': 'Body weight loss at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in body weight from baseline to 1 month'}, {'measure': 'Change in systolic blood pressure at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in systolic blood pressure from baseline to 3 monthes'}, {'measure': 'Change in diastolic blood pressure at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in diastolic blood pressure from baseline to 3 monthes'}, {'measure': 'Change in systolic blood pressure at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in systolic blood pressure from baseline to 2 monthes'}, {'measure': 'Change in diastolyc blood pressure at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in diastolyc blood pressure from baseline to 2 monthes'}, {'measure': 'Change in systolic blood pressure at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in systolic blood pressure from baseline to 1 month'}, {'measure': 'Change in diastolic blood pressure at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in diastolic blood pressure from baseline to 1 month'}, {'measure': 'Change in blood glucose at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in blood glucose level from baseline to 3 monthes'}, {'measure': 'Change in blood glucose at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in blood glucose level from baseline to 2 monthes'}, {'measure': 'Change in blood glucose at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in blood glucose level from baseline to 1 month'}, {'measure': 'Change in HbA1c at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in HbA1c (Glycated hemoglobin) percentage from baseline to 3 monthes'}, {'measure': 'Change in HbA1c at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in HbA1c (Glycated hemoglobin) percentage from baseline to 2 monthes'}, {'measure': 'Change in HbA1c at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in HbA1c (Glycated hemoglobin) percentage from baseline to 1 month'}, {'measure': 'Change in total cholesterol level at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in blood total cholesterol level from baseline to 3 monthes'}, {'measure': 'Change in total cholesterol level at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in blood total cholesterol level from baseline to 2 monthes'}, {'measure': 'Change in total cholesterol level at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in blood total cholesterol level from baseline to 1 months'}, {'measure': 'Change in triglycerides level at 3 monthes', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Change in blood triglycerides level from baseline to 3 monthes'}, {'measure': 'Change in triglycerides level at 2 monthes', 'timeFrame': 'from baseline to 2 monthes', 'description': 'Change in blood triglycerides level from baseline to 2 monthes'}, {'measure': 'Change in triglycerides level at 1 month', 'timeFrame': 'from baseline to 1 month', 'description': 'Change in blood triglycerides level from baseline to 1 month'}, {'measure': 'Metabolic Control of type 2 Diabetes at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse metabolic control of type 2 Diabetes at 3 months regarding baseline'}, {'measure': 'Clinical Control of arterial hypertension at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical control of arterial hypertension at 3 months regarding baseline'}, {'measure': 'Clinical Control of Hypercholesterolemia at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical control of Hypercholesterolemia at 3 months regarding baseline'}, {'measure': 'Clinical Control of Hypertriglyceridemia at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical control of Hypertriglyceridemia at 3 months regarding baseline'}, {'measure': 'Improvement of Sleep Apnea Obstructive Syndrome at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Sleep Apnea Obstructive Syndrome, regarding baseline.'}, {'measure': 'Improvement of Chronic Respiratory Disease at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Chronic Respiratory Disease, regarding baseline.'}, {'measure': 'Improvement of Obesity hypoventilation syndrome at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Obesity hypoventilation syndrome, regarding baseline.'}, {'measure': 'Improvement of Metabolic syndrome at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': '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.'}, {'measure': 'Improvement of Atrial fibrillation at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Atrial fibrillation, regarding baseline.'}, {'measure': 'Improvement of Cardiac insufficiency at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Cardiac insufficiency, regarding baseline.'}, {'measure': 'Improvement of Pulmonary hypertension at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Pulmonary hypertension, regarding baseline.'}, {'measure': 'Improvement of Cardiomyopathy at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of cardiomyopathy, regarding baseline.'}, {'measure': 'Improvement of Renal insufficiency at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Percentage of patients with better, equal or worse clinical symptoms of Renal insufficiency, regarding baseline.'}, {'measure': 'Obesity Surgery Mortality Risk Score', 'timeFrame': '3 months', 'description': 'Obesity Surgery Mortality Risk Score at the preoperative visit'}, {'measure': 'Length of surgery', 'timeFrame': 'During bariatric surgery', 'description': 'Length (in minuts) of bariatric surgery'}, {'measure': 'Length of anesthesia', 'timeFrame': 'During bariatric surgery', 'description': 'Length (in minuts) of anesthesia during bariatric surgery'}, {'measure': 'Number of patients with intraoperative complications', 'timeFrame': 'During bariatric surgery', 'description': 'Number of patients with intraoperative complications occurring during bariatric surgery and within the postoperative 24 hours'}, {'measure': 'Number of patients with postoperative complications after bariatric surgery', 'timeFrame': 'After bariatric surgery', 'description': 'Number of patients with postoperative complications occurring before hospital discharge'}, {'measure': 'Number of total days of hospitalization', 'timeFrame': 'After bariatric surgery', 'description': 'Number of total days of hospitalization after bariatric surgery'}, {'measure': 'Number of Participants With Adverse Events related to preoperative weight loss treatment', 'timeFrame': 'Through 3 months of study', 'description': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PnK® Method)'}, {'measure': 'Number of weight loss treatment dropout rate', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Number of weight loss treatment dropout rate from baseline to 3 months'}, {'measure': 'Number of patients who refuse bariatric surgery at 3 months', 'timeFrame': 'from baseline to 3 monthes', 'description': 'Number of patients who refuse bariatric surgery from baseline to 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PnK Method', 'obesity', 'very low calorie ketogenic diet', 'Comorbidity', 'Bariatric Surgery', 'weight loss'], 'conditions': ['Obesity, Morbid', 'Bariatric Surgery', 'Comorbidity']}, 'descriptionModule': {'briefSummary': 'Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.', 'detailedDescription': '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.\n\nPatients 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.\n\nThe 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, between 18 and 65 years old\n* 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).\n* Patients scheduled for bariatric surgery within 3 months ± 1 week.\n* Patients who, regardless of their inclusion in this study, will undergo treatment with the multidisciplinary slimming program in study or standard diet.\n* Patients who agree to participate and sign the Informed Consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Patients with type 1 diabetes mellitus or on insulin therapy\n* Patients with eating disorders, alcoholism, and/or drug addiction.\n* Patients with any severe psychological disorder (eg schizophrenia, bipolar disorder).\n* Patients receiving dicumarinic anticoagulants (Sintrom®) or cortisone.\n* Patients with liver failure.\n* Patients with severe kidney failure (gfr \\<30).\n* Patients with hemopathies.\n* Patients with cancer.\n* Patients with cardiovascular or cerebrovascular disease (heart rate disorders, recent infarction \\[\\<6m\\], unstable angina, decompensated heart failure, recent stroke \\[\\<6m\\]).\n* Patients in acute attack of gout.\n* Patients with renal lithiasis verified by ultrasound.\n* Patients with cholelithiasis verified by ultrasound.\n* Patients with depression.\n* Patients with electrolyte imbalance, according to medical criteria.\n* Patients with orthostatic hypotension.\n* Patients with contraindications to surgery'}, 'identificationModule': {'nctId': 'NCT03530566', 'briefTitle': 'Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Protein Supplies SL'}, 'officialTitle': 'Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery', 'orgStudyIdInfo': {'id': 'PRO-CBP-2017-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pnk group', 'description': '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', 'interventionNames': ['Other: PnK® Method']}, {'label': 'Control group', 'description': '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', 'interventionNames': ['Other: standard diet']}], 'interventions': [{'name': 'PnK® Method', 'type': 'OTHER', 'description': 'A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support', 'armGroupLabels': ['Pnk group']}, {'name': 'standard diet', 'type': 'OTHER', 'description': 'standard low calorie diet for weight loss', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'German Guzman, Ph', 'role': 'CONTACT', 'email': 'German.G@pronokal.com', 'phone': '+34 674366358'}, {'name': 'Montse Vidal, Ph', 'role': 'CONTACT', 'email': 'montsevidal@crossdata.es', 'phone': '+34 663825890'}], 'overallOfficials': [{'name': 'Davide De Carvalho, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar Sao Joao do Porto'}, {'name': 'Paula Freitas, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar Sao Joao do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protein Supplies SL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}