Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT03176056
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2017-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-31', 'size': 227575, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-29T00:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The improvement of glycemic control status', 'timeFrame': 'measured at baseline and every 3 months for 18 months after intervention', 'description': 'The reduction of HbA1c, fasting and 2-h glucose over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}, {'measure': 'The reduction of medication effect score (MES)', 'timeFrame': 'measured at baseline and every 3 months for 18 months after intervention', 'description': 'The MES assessed the overall utilization of hypoglycemic agents. The percentage of the maximum daily dose for each medication was multiplied by an adjustment factor and these products were summed to produce the final MES value. A higher MES value denoted a greater use of medication. The minimum score is 0 and without maximum score.The lower, the better. The reduction of MES over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}], 'secondaryOutcomes': [{'measure': 'The improvement of lipid profile', 'timeFrame': 'measured at baseline and every 3 months for 18 months after intervention', 'description': 'The reduction of total cholesterol, triglyceride, LDL and the increment of HDL after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}, {'measure': 'The improvement of small dense low density lipoprotein (sdLDL)', 'timeFrame': 'measured at baseline and every 6 months for 18 months after intervention', 'description': 'The reduction of sdLDL after intervention.The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}, {'measure': 'The maintenance of renal function', 'timeFrame': 'measured at baseline and every 3 months for 18 months after intervention', 'description': 'The change of serum creatinine after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}, {'measure': 'The improvement of microalbuminuria.', 'timeFrame': 'measured at baseline and 18 month after intervention', 'description': 'The reduction of microalbumin/creatine ratio after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}, {'measure': 'The improvement of carotid intima-media thickness (IMT)', 'timeFrame': 'measured at baseline and 18 month after intervention', 'description': 'The reduction of carotid IMT after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Low carbohydrate diet'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.', 'detailedDescription': 'Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes diagnosis ≧ 1 year\n* poorly controlled with HbA1c≧ 7.5% in the previous 3 months.\n* aged 20 to 80\n* without or with treatment \\[ oral hypoglycemic agents (OHA) and/or insulin treatment)\n\nExclusion Criteria:\n\n* pregnancy or lactating women\n* impaired renal function with serum creatinine ≧ 1.5 mg/dl\n* abnormal liver function \\[alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis\n* significant heart diseases (unstable angina, unstable heart failure)\n* frequent gout attacks (≧ 3 times/year)\n* participation in other weight loss programs or the use of weight-reducing drugs\n* eating disorders\n* could not complete the questionnaire\n* poor compliance to protocol.'}, 'identificationModule': {'nctId': 'NCT03176056', 'briefTitle': 'The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Low Carbohydrate Diet for Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '201504032RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low carbohydrate diet', 'description': 'Low carbohydrate diet limits carbohydrate \\<=90g/day', 'interventionNames': ['Dietary Supplement: Low carbohydrate diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calori restricted diet', 'description': 'Traditional diabetic diet', 'interventionNames': ['Dietary Supplement: Calori restricted diet']}], 'interventions': [{'name': 'Low carbohydrate diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'For the LCD group, the daily carbohydrate intake was limited to less than 90g, without any restriction to total energy. The concept of a LCD was introduced and an educational 15 g equivalent carbohydrate food list was provided. The easy conversion method is that 15 g equivalent carbohydrate =1/4 bowel of rice= 1/2 bowel of noodle = 1 slice of toast = 3 soup-spoon of oats = one bowl of fruit =1/2 regular size banana= one glass of milk = 3 dumplings. Less than two equivalent 15g-carbohydrate intakes per meal were advised.', 'armGroupLabels': ['Low carbohydrate diet']}, {'name': 'Calori restricted diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'For the calori restricted diet group, the target total calorie intake was calculated by multiplying the ideal body weight by 25 kcal/kg for those with a BMI in the range 18.5 to 24, 20 kcal/kg for obese subjects with a BMI \\> 24 and 30 kcal/day for underweight subjects with a BMI \\<18.5. The macronutrient percentage was 50-60% for carbohydrate, 1.0-1.2 g/kg for protein and fat ≦30%.', 'armGroupLabels': ['Calori restricted diet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chin-Ying Chen, MD, MHSc', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital and National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}