Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT00940966
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2009-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D000092244', 'term': 'Isolated Systolic Hypertension'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADA diet', 'low carbohydrate diet', 'Metabolic syndrome'], 'conditions': ['Elevated Triglycerides', 'Systolic Hypertension', 'Insulin Resistance', 'Abdominal Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.", 'detailedDescription': "The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.\n\nWe plan to address the following issues:\n\n1. To test the hypothesis that a controlled carbohydrate nutrition plan will be superior to the standard ADA diet in controlling blood sugar (as measured by glycosylated hemoglobin \\[HbA1C\\]), decreasing cardiovascular risk factors (Serum Lipid Levels, Blood Pressure) and decreasing weight in adolescents with metabolic syndrome\n2. To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in these patients as measured by the SF-10 for Children, the Brief Symptom Inventory (BSI) and a scaled questionnaire regarding side effects.\n3. To compare two different maintenance programs in the group who receive the non- energy restricted very-low carbohydrate diet and compare each group to the group"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents and young adults ages 13-18 with a BMI\\>95% for age or over 30 for young adults, with pre-existing metabolic syndrome\n\nExclusion Criteria:\n\n* Subjects on any chronic medication other than antihistamines, asthma medications, oral contraceptives or diabetes medications, smoke more than 5 cigarettes/day, suffer from alcoholism or drug abuse or have any significant abnormality not associated with metabolic syndrome on screening labs will be excluded from randomization.\n* Subjects currently taking Byetta will be excluded from the study, as a side effect of the drug is weight loss.\n* Subjects with familial hypercholesteremia may be excluded if the investigator considers the history to be severe. The data collected from subjects with a HBA1C greater than 12.5 will be analyzed in a separate group, although they will still be randomized to one of the three treatment groups. This is due to the fact that past experience has shown that these individuals run a high risk of being non-compliant with medication use, diet, and exercise plans. Results from this group will be reported separately.\n* Subjects who are pregnant or those desiring pregnancy will be excluded, as the safety of this intervention in pregnancy has not been established.'}, 'identificationModule': {'nctId': 'NCT00940966', 'briefTitle': 'A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'CAMC Health System'}, 'officialTitle': 'A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome', 'orgStudyIdInfo': {'id': '06-02-1776'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'energy restricted very-low carbohydrate', 'description': 'non-energy restricted ketogenic diet .', 'interventionNames': ['Dietary Supplement: energy restricted very-low carbohydrate diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ADA diet', 'description': 'standard ADA diet', 'interventionNames': ['Dietary Supplement: standard ADA diet', 'Dietary Supplement: energy restricted very-low carbohydrate diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low glycemic index', 'description': 'restricted ketogenic diet', 'interventionNames': ['Dietary Supplement: low glycemic diet']}], 'interventions': [{'name': 'standard ADA diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'standard ADA diet', 'armGroupLabels': ['ADA diet']}, {'name': 'energy restricted very-low carbohydrate diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'energy restricted very-low carbohydrate diet', 'armGroupLabels': ['ADA diet', 'energy restricted very-low carbohydrate']}, {'name': 'low glycemic diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ketogenic diet.'], 'description': 'restricted ketogenic diet', 'armGroupLabels': ['low glycemic index']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25302', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Wvu Department of Pediatrics', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Steven Sondike, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WVU Department of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CAMC Health System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Steven sondike MD', 'oldOrganization': 'WVU department of pediatrics'}}}}