Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-20 @ 8:17 AM
Study NCT ID:
NCT02169050
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2014-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma Adipose tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-18', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Glucose Insulin Sensitivity (OGIS)', 'timeFrame': '2 hour, 1-5 weeks before bariatric surgery', 'description': 'Insulin sensitivity is assessed based with a 2-hour, 75gm Oral Glucose Tolerance Test. Blood samples are collected at 0, 90, and 120 min for the measurement of glucose and insulin.'}], 'secondaryOutcomes': [{'measure': 'Adipose tissue mRNA Expression of Vitamin D Receptors and Inflammation Markers', 'timeFrame': '10-20 minutes, during bariatric surgery'}, {'measure': 'Inflammatory markers in plasma', 'timeFrame': '3-15 minutes, 1-5 weeks before bariatric surgery', 'description': 'Fasting blood drawn on Oral Glucose Tolerance Test day, which is 1-5 weeks before bariatric surgeries'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D deficiency', 'Inflammation', 'Obesity'], 'conditions': ['Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent rickets; however, recently it has been recognized to inversely associate with many non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing inflammation in human adipose tissues. The main objective of this study was to assess the association between vitamin D and insulin sensitivity and inflammation in morbidly obese pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and insulin. Also, to better understand the potential mechanism and the role circulating vitamin D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA) expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric procedure. We hypothesized that subjects with higher serum vitamin D levels would be less inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory markers compared to those with lower serum vitamin D levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects are drawn from women seeking surgical treatment for their morbid obesity at the University of Illinois at Chicago Medical Center (UICMC) Bariatric surgery clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Premenopausal women between the age of 21 and 49 years old\n* BMI \\>=35(kg/m2)\n* Not pregnant\n* English speaking\n* Approved for a bariatric surgery\n\nExclusion Criteria:\n\nSubjects with:\n\n* Diabetes\n* Cancer\n* Kidney disease\n* Liver disease\n* Gallbladder disease\n* Rheumatoid arthritis\n* HIV/AIDS\n* Crohn's disease or inflammatory bowel disease\n* Subjects taking anti-inflammatory medications"}, 'identificationModule': {'nctId': 'NCT02169050', 'acronym': 'VitD2014', 'briefTitle': 'Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Vitamin D, Inflammation, and Relations to Insulin Resistance in Morbidly Obese Pre-Menopausal Women', 'orgStudyIdInfo': {'id': '2010-1010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No intervention', 'description': 'There is no intervention to subjects in this study. All subjects are morbidly women seeking bariatric surgeries.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Carol Braunschweig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}