Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-03 @ 4:26 AM
Study NCT ID:
NCT03671733
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients
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': 'D000077270', 'term': 'Exenatide'}, {'id': 'D007267', 'term': 'Injections'}], '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'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change at 3 months', 'timeFrame': 'baseline , 3 months', 'description': 'Measured in kilograms'}], 'secondaryOutcomes': [{'measure': 'Change in waist circumference', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in cm'}, {'measure': 'Change in systolic blood pressure', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmHg'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmHg'}, {'measure': 'Change in HbA1c', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in %'}, {'measure': 'Change in plasma glucose', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in insulin', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in μU/ml'}, {'measure': 'Change in lipids-total cholesterol', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in lipids-low density lipoprotein cholesterol', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in lipids-high density lipoprotein cholesterol', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in lipids-triglycerides', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in lipids-free fatty acids', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in μmol/l'}, {'measure': 'Change in Uric Acid', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in interleukin-6', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}, {'measure': 'Change in tumor necrosis factor', 'timeFrame': 'baseline and 3 months', 'description': 'Measured in mmol/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This studay evaluates the effect of the glucagon-like peptide-1 (GLP-1) receptor agonist,including Liraglutide,Exenatide and Exenatide Microspheres for Injection,in the treatment of subjects who are overweight or obese.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 65 years (to the date of screening)；\n2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).\n3. Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.\n4. Weight stable for more than 3 months (weight fluctuations \\<5%).\n\nExclusion Criteria:\n\n1. pregnant female.\n2. Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.\n3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.\n4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.\n5. Nearly a month had surgery, trauma, infection and so on.\n6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.\n7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).'}, 'identificationModule': {'nctId': 'NCT03671733', 'briefTitle': 'Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients', 'orgStudyIdInfo': {'id': '201806897'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'description': 'Administered subcutaneously (s.c., under the skin) once daily for 12 weeks.', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Exenatide', 'description': 'Administered subcutaneously (s.c., under the skin) twice daily for 12 weeks.', 'interventionNames': ['Drug: Exenatide']}, {'type': 'EXPERIMENTAL', 'label': 'Exenatide Microspheres for Injection', 'description': 'Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.', 'interventionNames': ['Drug: Exenatide Microspheres for Injection']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards, 1.8mg per day, subcutaneous injection.', 'armGroupLabels': ['Liraglutide']}, {'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': '10mcg once a day for 4 weeks increased to 10mcg twice a day for 8 weeks.', 'armGroupLabels': ['Exenatide']}, {'name': 'Exenatide Microspheres for Injection', 'type': 'DRUG', 'otherNames': ['Bydureon'], 'description': 'Exenatide 2 mg injection once weekly for 12 weeks.', 'armGroupLabels': ['Exenatide Microspheres for Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Wu', 'role': 'CONTACT', 'email': 'wujing0731@163.com', 'phone': '+86-13574120508'}], 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Jing Wu', 'role': 'CONTACT', 'email': 'wujing0731@163.com', 'phone': '+86-13574120508'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}