Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01940302
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2013-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2013-09-07', 'studyFirstSubmitQcDate': '2013-09-07', 'lastUpdatePostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic Control', 'timeFrame': 'Twelve weeks', 'description': 'Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malnutrition; Metabolic disorders'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:\n\n (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;\n* Subject is between 18 and 75 years of age, inclusive.\n* Subject's BMI is \\>18.5 kg/m2 and \\<35 kg/m2.\n* If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.\n\nExclusion Criteria:\n\n* Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.\n* Subject that use exogenous insulin for glucose control.\n* Subject that has a history of diabetic ketoacidosis.\n* Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.\n* Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.\n* Subject that has had operation less than six months prior to screening visit.\n* Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.\n* Subject is known to be allergic or intolerant to any ingredient found in the study product."}, 'identificationModule': {'nctId': 'NCT01940302', 'briefTitle': 'Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Shaoguan University'}, 'officialTitle': 'Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'SGU-03'}, 'secondaryIdInfos': [{'id': '2012BAD33B10', 'type': 'OTHER', 'domain': 'National Key Technology Research and Development Program of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEHEL multi-nutrients supplement', 'description': '75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.', 'interventionNames': ['Dietary Supplement: LEHEL multi-nutrients supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Received only oral hypoglycemic agents.'}], 'interventions': [{'name': 'LEHEL multi-nutrients supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.', 'armGroupLabels': ['LEHEL multi-nutrients supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '512005', 'city': 'Shaoguan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shaoguan University', 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}], 'overallOfficials': [{'name': 'Wenhua Ling, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaoguan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}