Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT04575194
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C000621664', 'term': 'Naltrexone-Bupropion combination'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in blood pressure', 'timeFrame': '3 and 6 months', 'description': 'Blood pressure as assessed by 24-hour recording (numerical scale)'}], 'secondaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '3 and 6 months', 'description': 'Percentage of weight lost will be measured by an electronic scale (numerical scale)'}, {'measure': 'Changes in glycemic', 'timeFrame': '3 and 6 months', 'description': 'Measurement of HbA1c will be measured biochemically (numerical scale)'}, {'measure': 'Changes in lipemic profile', 'timeFrame': '3 and 6 months', 'description': 'Total cholesterol, Triglycerides, LDL-C, HDL-C will be measured biochemically (numerical scale)'}, {'measure': 'Percentage of visceral fat', 'timeFrame': '3 and 6 months', 'description': 'Measurement of visceral fat by bioimpedance analysis (numerical scale)'}, {'measure': 'Fat mass', 'timeFrame': '3 and 6 months', 'description': 'Measurement of fat mass by bioimpedance analysis (numerical scale)'}, {'measure': 'Fat free mass', 'timeFrame': '3 and 6 months', 'description': 'Measurement of fat free mass by bioimpedance analysis (numerical scale)'}, {'measure': 'Autonomic nervous system function', 'timeFrame': '3 and 6 months', 'description': 'Measurement of heart rate variability will be measured through Ewing score and Spectral analysis testing (numerical scale)'}, {'measure': 'Changes in meal induced thermogenesis', 'timeFrame': '3 and 6 months', 'description': 'Measurement through indirect calorimetry and assessment of changes in Resting Metabolic Rate (RMR) (numerical scale)'}, {'measure': 'Changes in gut hormones involved in appetite regulation', 'timeFrame': '3 and 6 months', 'description': 'Measurement in plasma before and after the intervention during a mixed meal test will be measured through ELISA kits (numerical scale)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '37418844', 'type': 'DERIVED', 'citation': 'Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.', 'detailedDescription': "This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise. Patient groups will be comparable in age, gender and BMI.\n\nThe aim of the study is the comparison of the efficacy of liraglutide vs. naltrexone/bupropion in metabolic and cardiovascular markers.\n\nThe following parameters will be measured:\n\n* Weight, height, waist and hip circumference\n* 24-hour recording of blood pressure and heart rate\n* HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio\n* Bioelectric impedance for determination of total and visceral fat and muscle mass Indirect calorimetry for the determination of resting metabolic rate and total energy expenditure\n* Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to investigate the function of the autonomic nervous system\n* Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin concentration and gastrointestinal hormones involved in hunger and satiety with modern indirect calorimetry to determine postprandial thermogenic analog scales (VAS)\n* Neuropathy tests\n* Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling of hunger and satiety\n* Echocardiographic determination of the left systolic and telodiastolic diameter of the left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication\n* Pericardial fat"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.\n\nExclusion Criteria:\n\n1. Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone\n2. Bariatric surgery\n3. Diabetes type 2\n4. Active malignancy\n5. Medication that affects weight (eg corticosteroids, phenothiazines)'}, 'identificationModule': {'nctId': 'NCT04575194', 'briefTitle': 'Study of the Cardiometabolic Effects of Obesity Pharmacotherapy', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity', 'orgStudyIdInfo': {'id': 'Obesity drugs study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide 3 mg', 'description': 'Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.', 'interventionNames': ['Drug: Liraglutide 6 MG/ML [Saxenda]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naltrexone/bupropion 32/360 mg', 'description': 'Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.', 'interventionNames': ['Drug: Naltrexone-Bupropion Combination']}], 'interventions': [{'name': 'Liraglutide 6 MG/ML [Saxenda]', 'type': 'DRUG', 'description': '3 mg of sc liraglutide daily plus lifestyle intervention', 'armGroupLabels': ['Liraglutide 3 mg']}, {'name': 'Naltrexone-Bupropion Combination', 'type': 'DRUG', 'description': '32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention', 'armGroupLabels': ['Naltrexone/bupropion 32/360 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Alexandros Kokkinos, MD, PhD', 'role': 'CONTACT', 'email': 'rjd@otenet.gr', 'phone': '2132061248'}], 'facility': 'First Department of Propaedeutic Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Alexandros Kokkinos, MD, PhD', 'role': 'CONTACT', 'email': 'rjd@otenet.gr', 'phone': '+302132061248'}, {'name': 'Georgia Argyrakopoulou, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'gargyrakopoulou@gmail.com', 'phone': '+306972284033'}], 'overallOfficials': [{'name': 'Alexandros Kokkinos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Athens Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Internal Medicine', 'investigatorFullName': 'Alexandros Kokkinos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}