Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 4:12 PM
Study NCT ID:
NCT02272556
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Role of the Polyol Pathway in the Central Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cerebrospinal fluid cell count', 'timeFrame': '2 weeks post MRS testing', 'description': 'Metabolite levels will be measure in collected spinal fluid'}, {'measure': 'protein levels', 'timeFrame': '2 weeks post MRS testing', 'description': 'Metabolite levels will be measure in collected spinal fluid'}], 'primaryOutcomes': [{'measure': 'Metabolite Measurements by MRS', 'timeFrame': '4 hours post hyperglycemia', 'description': 'metabolite levels will be measured by MRS'}], 'secondaryOutcomes': [{'measure': 'Hunger Ratings', 'timeFrame': '4 hours post hyperglycemia', 'description': 'Hunger will be measured using a visual analog scale'}, {'measure': 'Satiety Ratings', 'timeFrame': '4 hours post hyperglycemia', 'description': 'Satiety will be measured using a visual analog scale'}, {'measure': 'Cognitive State', 'timeFrame': '4 hours post hyperglycemia', 'description': 'Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \\> 30 kg/m\\^2) OR age-matched lean, healthy control subjects (BMI \\< 25 kg/m\\^2)\n* Age 18-55\n* BMI 18-45 kg/m\\^2\n\nExclusion Criteria:\n\n* Creatinine \\> 1.5 mg/dL\n* Hgb \\< 10 mg/dL\n* ALT \\> 2.5 x ULN\n* Untreated thyroid disease\n* Uncontrolled Hypertension\n* Known Neurological Disorders\n* Untreated Psychiatric Disorders\n* Malignancy\n* Bleeding Disorders\n* Smoking\n* Current or recent steroid use in last 3 months\n* Illicit drug use\n* Pregnancy, actively seeking pregnancy, or breastfeeding\n* Inability to enter MRI/MRS'}, 'identificationModule': {'nctId': 'NCT02272556', 'briefTitle': 'Investigating the Role of the Polyol Pathway in the Central Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Investigating the Role of Polyol Pathway in the Central Nervous System', 'orgStudyIdInfo': {'id': '1408014461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects with Type 2 Diabetes', 'description': 'Type 2 DM subjects with HbA1C \\> 7.5% treated with metformin, sulfonylurea, insulin or combination', 'interventionNames': ['Other: Brain MRS during hyperglycemic clamp', 'Other: Analysis of Metabolites in cerebrospinal fluid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Diabetic Obese', 'description': 'Age-matched, non-diabetic obese (BMI \\> 30 kg/m\\^3) individuals', 'interventionNames': ['Other: Brain MRS during hyperglycemic clamp', 'Other: Analysis of Metabolites in cerebrospinal fluid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lean, healthy control subjects', 'description': 'Age-matched, lean, healthy control subjects (BMI \\< 25 kkg/m\\^3)', 'interventionNames': ['Other: Brain MRS during hyperglycemic clamp', 'Other: Analysis of Metabolites in cerebrospinal fluid']}], 'interventions': [{'name': 'Brain MRS during hyperglycemic clamp', 'type': 'OTHER', 'description': 'All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique', 'armGroupLabels': ['Lean, healthy control subjects', 'Non-Diabetic Obese', 'Subjects with Type 2 Diabetes']}, {'name': 'Analysis of Metabolites in cerebrospinal fluid', 'type': 'OTHER', 'description': 'All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid', 'armGroupLabels': ['Lean, healthy control subjects', 'Non-Diabetic Obese', 'Subjects with Type 2 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Robert Sherwin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}