Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT01199692
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Metabolic Biomarkers in Varying Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, stool, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2 Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain elusive. More positively, the identification of a scientific resolution for obesity and T2D in the short-term is not outside the bounds of reality. Because the complexity of metabolic regulation is likely to include already characterized biomarkers, as well as other unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements, and disease states to discover associations and pathways related to the restoration of normal metabolism.', 'detailedDescription': 'As an observational study design, study investigators will prospectively identify potential subjects from various primary care and/or specialty care clinics in Western New York. Prior to the commencement of any study procedures, subjects will document informed consent and acknowledgement of HIPPA rights. Following approval from their practitioner, subjects may be asked on multiple occasions to complete or undergo any or all of the following types of study procedures:\n\n* Medical record review and follow-up\n* Fasting blood sample (volume limitations stipulated within)\n* Pre-meal, during meal, and post-meal blood sample (volume limits within)\n* Short-term and/or long-term dietary intervention (MD approved)\n* Short-term and/or long-term exercise intervention (MD approved)\n* Blood glucose log\n* Food and exercise diaries\n* Pre- and post-medication blood sampling (neutraceutical or Rx products)\n* 24-hour urine sampling\n* Spot urine sampling\n* Stool microbiologic sampling\n* Intestinal microbiologic sampling (gastric bypass subjects only)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age =\\>18\n* Weight =\\>110 pounds\n\nExclusion Criteria:\n\n* Age \\<18\n* Weight \\<110 pounds\n* Pregnant\n* Poor venous access or poor likelihood to adhere with study procedures'}, 'identificationModule': {'nctId': 'NCT01199692', 'briefTitle': 'Characterization of Metabolic Biomarkers in Varying Subjects', 'organization': {'class': 'OTHER', 'fullName': 'CPL Associates'}, 'officialTitle': 'Characterization of Metabolic Biomarkers in Subjects of Varying Age, Gender, Ethnicity, Body Mass Distribution, Dietary Habits, Exercise Habits, Medication Requirements, and Disease State Burden', 'orgStudyIdInfo': {'id': 'CPL201006A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age'}, {'label': 'Gender'}, {'label': 'Ethnicity'}, {'label': 'Body Mass Distribution'}, {'label': 'Dietary Habits'}, {'label': 'Exercise Habits'}, {'label': 'Medication Requirements'}, {'label': 'Disease State Burden'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Synergy Bariatrics, A Department of ECMC', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}], 'overallOfficials': [{'name': 'Scott Monte, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPL Associates, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CPL Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director', 'investigatorFullName': 'Scott Monte', 'investigatorAffiliation': 'CPL Associates'}}}}