Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:37 PM
Study NCT ID:
NCT04469400
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2020-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention for Patients With Impaired Glucose Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-07-12', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': 'ten weeks'}, {'measure': 'Blood glucose 2 hours after meal', 'timeFrame': 'ten weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)\n\n * 24 kg/m2 ≤ BMI ≤ 35 kg/m2\n\n * Those who are willing to accept assessment and sign informed consent.\n\nExclusion Criteria:\n\n* Patients diagnosed with diabetes or undergoing diabetes treatment;\n\n * Receiving drugs or surgery for weight loss at present or in the past 3 months;\n\n * Receiving corticosteroid or thyroid hormone treatment;\n\n * Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;\n\n * Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;\n\n * Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.'}, 'identificationModule': {'nctId': 'NCT04469400', 'briefTitle': 'Lifestyle Intervention for Patients With Impaired Glucose Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation', 'orgStudyIdInfo': {'id': '2019-317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group1', 'description': 'Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.'}, {'type': 'EXPERIMENTAL', 'label': 'Group2', 'description': 'In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients', 'interventionNames': ['Dietary Supplement: Low fat diet intensive intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group3', 'description': 'In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients', 'interventionNames': ['Other: Low-Carbon Water Diet Intensive Intervention']}], 'interventions': [{'name': 'Low fat diet intensive intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': 'education and Compound protein solid beverage', 'armGroupLabels': ['Group2']}, {'name': 'Low-Carbon Water Diet Intensive Intervention', 'type': 'OTHER', 'description': 'education and Nutrition bar', 'armGroupLabels': ['Group3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315300', 'city': 'Cixi', 'state': 'Zhejiang', 'country': 'China', 'facility': "Cixi People's Hospital", 'geoPoint': {'lat': 30.1764, 'lon': 121.2457}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '321000', 'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Jinhua municipal central hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '323020', 'city': 'Lishui', 'state': 'Zhejiang', 'country': 'China', 'facility': "Lishui People's Hospital", 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}, {'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo Huamei Hospital, University of Chinese Academy of Sciences', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '312000', 'city': 'Shaoxing', 'state': 'Zhejiang', 'country': 'China', 'facility': "Shaoxing People's Hospital", 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital of Wenzhou medical university', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '315400', 'city': 'Yuyao', 'state': 'Zhejiang', 'country': 'China', 'facility': "Yuyao People's Hospital", 'geoPoint': {'lat': 30.05, 'lon': 121.14944}}], 'overallOfficials': [{'name': 'Pianhong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}