Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT04116905
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2019-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The remission rate of metabolic syndrome', 'timeFrame': '12 months', 'description': 'Participants are considered to have achieved metabolic syndrome remission when they meet ≤2 of the following 5 diagnostic criteria:\n\n1. Waist circumference ≥85 cm (men) / ≥80 cm (women);\n2. Fasting triglycerides ≥1.7 mmol/L or current lipid-lowering therapy;\n3. HDL cholesterol \\<1.04 mmol/L (men) / \\<1.30 mmol/L (women);\n4. Systolic BP ≥130 mmHg and/or diastolic BP ≥85 mmHg, or diagnosed hypertension with antihypertensive treatment;\n5. Fasting glucose ≥5.6 mmol/L, or diagnosed type 2 diabetes with glucose-lowering treatment.\n\nRemission is defined as sustained resolution of ≥3 criteria.'}, {'measure': 'The proportion of participants achieving 15% weight loss from baseline', 'timeFrame': '12 months', 'description': 'The proportion of participants achieving 15% weight loss from baseline'}], 'secondaryOutcomes': [{'measure': 'Remission of hypertension', 'timeFrame': '12 months', 'description': 'The proportion of participants achieving target blood pressure control (either \\<130/85 mmHg or \\<140/90 mmHg) without antihypertensive medication.'}, {'measure': 'Remission of hyperglycemia', 'timeFrame': '12 months', 'description': 'The proportion of participants achieving fasting plasma glucose \\<5.6 mmol/L without glucose-lowering medication.'}, {'measure': 'Remission of hypertriglyceridemia', 'timeFrame': '12 months', 'description': 'The proportion of participants achieving triglyceride levels \\<1.7 mmol/L without lipid-lowering therapy.'}, {'measure': 'Remission of low HDL-C', 'timeFrame': '12 months', 'description': 'The sex-specific proportion achieving therapeutic HDL-C targets (≥1.04 mmol/L in males; ≥1.30 mmol/L in females) without lipid-modifying therapy.'}, {'measure': 'Remission of central obesity', 'timeFrame': '12 months', 'description': 'Proportion meeting gender-stratified waist circumference criteria (males \\<85 cm; females \\<80 cm).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metablolic syndrome', 'remission', 'life style', 'weight loss'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese Chinese individuals. The study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic syndrome remission. Additionally, the research will explore the potential mechanisms underlying these therapeutic effects.', 'detailedDescription': 'Background:\n\nMetabolic syndrome is a global public health concern, with prevalence rates ranging from 10% to 84% across different populations. It is strongly associated with multiple chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, and certain cancers. Notably, obesity plays a central role in the development of metabolic syndrome, and substantial evidence supports the benefits of significant weight loss in improving its components. Currently, there is a lack of research on lifestyle interventions aimed at weight loss to alleviate metabolic syndrome in affected populations.\n\nStudy Design:\n\nThis study is a single-center, prospective, randomized controlled trial. Metabolic syndrome (MetS) subjects aged 18-60 years were enrolled and randomly assigned to either an intensive lifestyle intervention group (a low-carbohydrate diet combined with physical exercise, target weight loss of 15%) or a conventional lifestyle intervention group ( energy-restricted diet combined with physical exercise, target weight loss of 7%). Participants underwent a 5-month weight-loss intervention (with monthly follow-ups) followed by a 7-month weight-maintenance phase (with follow-ups every 2 months). During the follow-up period, anthropometric and laboratory parameters were regularly monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI of 27-45 kg/m2\n* Metabolic syndrome: meet at least 3 of the following 5 criteria: waist circumference ≥85 cm (male) or 80 cm (female); TG ≥1.7 mmol/L or with lipid-lowering treatment; HDL\\<1.04 mmol/L(male) /1.3 mmol/L (female)；SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6 mmol/L and / or with diagnosed type 2 diabetes and hypoglycemic treatment. (If with type 2 diabetes, the process of the disease should not exceed 6 years, with the level of C-P ≥3/4 of the lower limit of limit; if with hypertension, BP ≤ 180/110 mmHg without anti-hypertensive agent, or BP ≤160/100 mmHg with 1-2 kinds of anti-hypertensive agents, or BP ≤140/90 mmHg with 3-4 kinds of anti-hypertensive agents; if with hyper-triglyceridemia, TG ≤ 11.2 mmol/L without lipid-lowering agent, or TG ≤ 5.6 mmol/L with lipid-lowering agent.)\n* Han Chinese\n* Willingness to participate\n\nExclusion Criteria:\n\n* Participants with metabolic syndrome caused by other secondary factors (genetic diseases related to obesity and hyperlipidemia, Cushing's syndrome, drug-induced obesity and etc.);\n* Participants whose body weight fluctuated by more than 5 kg in the last 6 months; who trying to lose weight in the last 3 months; who had used anti-obesity drugs, oral contraceptive, or glucocorticoids in the last 3 months;\n* Participants with Type 1 diabetes or gestational diabetes or other types of diabetes;\n* Participants with BP ≥ 180/110 mmHg, or malignant hypertension;\n* Participants with previous severe gastrointestinal diseases;\n* Participants with significant dysfunction of heart, liver, kidney and systemic organs (NYHA Class III or IV; ALT and / or AST ≥ 4 times the normal upper limit; GFR \\< 60 ml/min) or with malignant tumor;\n* Participants with drug abuse or alcohol addiction; with serious mental and neurological disorders;\n* Pregnant or lactating women; those who have planned to give birth within the past 1 year;\n* Participants with special dietary requirements, or with soy products, milk and other daily food allergies;\n* Participants in other clinical trials."}, 'identificationModule': {'nctId': 'NCT04116905', 'acronym': 'INSLIMS', 'briefTitle': 'Intensive Lifestyle Intervention for Remission of Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Intensive Lifestyle Interventions for Remission of Metabolic Syndrome in Overweight or Obese Individuals', 'orgStudyIdInfo': {'id': 'LIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Lifestyle Intervention', 'description': 'Participants randomized to the intensive lifestyle intervention arm will receive a structured, multi-component program consisting of both individualized counseling and group-based sessions. This intervention is specifically designed to facilitate achievement of a clinically significant 15% weight reduction and support long-term weight maintenance."', 'interventionNames': ['Behavioral: Intensive Lifestyle Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Treatment', 'description': 'Participants in the conventional treatment arm receive structured group-based education sessions focusing on metabolic syndrome management principles and peer support, with the therapeutic goal of achieving a modest 7% weight reduction', 'interventionNames': ['Behavioral: Conventional Treatment']}], 'interventions': [{'name': 'Intensive Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'The intensive lifestyle intervention program employs a structured, multi-component approach under professional supervision to achieve and sustain 15% weight reduction from baseline. This 12-month intervention features:\n\n1. A weight loss phase (months 1-5) incorporating:\n\n Individualized calorie restriction using partial meal replacement (carbohydrate energy supply ratio is 20\\~25%, and the daily calorie intake is 22.5\\*70% kcal/kg/d); exercise recommends at least 150 min of moderate intensity and 2 to 3 resistance training per week; with monthly follow-ups；\n2. A maintenance phase (months 6-12) focusing on:\n\n Healthy balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommends at least 150 minutes of moderate intensity and 2-3 resistance training per week; with follow-ups every 2 months；\n3. Digital health integration:\n\nMobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.', 'armGroupLabels': ['Intensive Lifestyle Intervention']}, {'name': 'Conventional Treatment', 'type': 'BEHAVIORAL', 'description': 'The conventional treatment arm receive standardized metabolic syndrome management through monthly group education sessions and peer support, with a target of 7% weight reduction from baseline. The program incorporates:\n\n1. A weight loss phase (months 1-5) incorporating:\n\n Structured lifestyle education; limit the total energy diet (total daily calorie intake is 22.5\\*85% kcal/kg/d), with carbohydrates, fat, proteins accounting for 45-55%, 20-30%, and 20-30%, respectively, for the daily energy intake.; physical activity(150 min medium intensity exercise and 2 to 3 resistance training); with monthly follow-ups;\n2. A maintenance phase (months 6-12) focusing on:\n\n Healthy balanced diet, total daily calorie intake is 20\\~25 kcal/kg/d; physical activity(150 min medium intensity exercise and 2 to 3 resistance training);with follow-ups every 2 months;\n3. Digital health integration:\n\nMobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.', 'armGroupLabels': ['Conventional Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Pengfei Shan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, {'name': 'Yuezhong Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}