Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01151605
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2010-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Suppression of Toll Like Receptors by Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007332', 'term': 'Insulin Infusion Systems'}], 'ancestors': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007260', 'term': 'Infusion Pumps'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-01', 'studyFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2010-06-25', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Suppression of Toll Like receptors by Insulin', 'timeFrame': '24 hours', 'description': 'Expression of TLR2, TLR4, TLR7 and TLR9 mRNA in mononuclear cells and adipose tissue'}], 'secondaryOutcomes': [{'measure': 'TLR expression', 'timeFrame': '0 hours', 'description': 'Basal TLR expression in obese and type 2 diabetic subjects as compared to lean subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease.', 'detailedDescription': 'Obesity and type 2 diabetes are major health problems in the United States and the world. Both conditions are characterized by increased inflammation and oxidative stress and are associated with increased risk of cardiovascular disease.\n\nOur previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect, on circulating blood cells and in plasma in healthy subjects and in critically ill patients.\n\nToll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses and are major determinants of the inflammatory response against foreign pathogens. In view of the recent data showing that TLRs recognize a range of molecules and proteins that are not of pathogenic source like saturated lipids and that TLRs are involved in the pathogenesis of atherosclerosis which leads to cardiovascular disease and insulin resistance which leads to type 2 diabetes (DM) we hypothesized that insulin infusion suppresses TLRs expression.\n\nOur preliminary data show that insulin infusion for 4 hours reduces the levels of many TLRs and thus might protect from inflammation induced conditions We therefore propose to investigate, in more detail, the effect of infusing different doses of insulin on TLRs mRNA and protein levels and its activity in obese and DM subjects over a longer infusion period and a larger number of subjects in circulating white blood cells and in fat tissue. Also we will be comparing the baseline levels of TLRs and TLRs related proteins as well as their modulation by insulin between normal, obese and DM subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nLean Group:\n\n1. Age: 20 to 65 years of age inclusive\n2. Sex: male or female\n3. Normal fasting plasma glucose (65-100 mg/dl)\n4. Normal BMI (20-25)\n\nObese Group:\n\n1. Age: 20 to 65 years of age inclusive\n2. Sex: male or female\n3. Normal fasting plasma glucose (65-100 mg/dl)\n4. BMI\\> 30\n\nDM Group:\n\n1. Type 2 Diabetes Mellitus\n2. Age: 20 to 65 years of age inclusive\n3. Sex: male or female\n4. BMI \\>30\n5. Hba1c \\< 8%\n6. If on statins, angiotensin converting enzyme inhibitor, angiotensin receptor blocker or low dose aspirin, should be on a stable dose for one month.\n\nEXCLUSION CRITERIA\n\n1. Pregnancy\n2. Congestive heart failure\n3. Heart Rate \\<50 beats /minute\n4. Sick Sinus Syndrome\n5. Second or third degree heart block\n6. Blood pressure \\<80 mm systolic or \\> 160/100 mmHg\n7. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous three months\n8. Hepatic disease (transaminase \\> 3 times normal)\n9. Renal impairment (serum creatinine \\> 1.5)\n10. History of drug or alcohol abuse within past one year\n11. Participation in any other concurrent clinical trial\n12. Potassium (K+) values \\<3.5 meq/l to \\> 5.5 meq/l)\n13. Any other life-threatening, non-cardiac disease\n14. Use of an investigational agent or therapeutic regimen within 30 days of study\n15. Type 2 diabetics on thiazolidinediones and/ or insulin\n16. Subjects on steroids, NSAIDS or antioxidants\n17. Patients taking exenatide or sitaglipin or loop diuretics\n18. Anemia (Hemoglobin level less than 12gm/dl in females and 13gm/dl in males) 19)Allergy to lidocaine'}, 'identificationModule': {'nctId': 'NCT01151605', 'briefTitle': 'The Suppression of Toll Like Receptors by Insulin', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'The Suppression of Toll Like Receptors by Insulin', 'orgStudyIdInfo': {'id': '1934'}, 'secondaryIdInfos': [{'id': '708CR13', 'type': 'OTHER_GRANT', 'domain': 'American Diabetes Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'obese subjects', 'description': 'obese (BMI \\>30Kg/m2) subjects infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr', 'interventionNames': ['Drug: insulin infusion', 'Drug: Dextrose infusion', 'Drug: Saline Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal weight subjects', 'description': 'Normal weight subjects infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr', 'interventionNames': ['Drug: insulin infusion', 'Drug: Dextrose infusion', 'Drug: Saline Infusion']}, {'type': 'EXPERIMENTAL', 'label': 'obese type 2 diabetes subjects', 'description': 'obese (BMI \\>30Kg/m2) subjects with type 2 diabetes infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr', 'interventionNames': ['Drug: insulin infusion', 'Drug: Dextrose infusion', 'Drug: Saline Infusion']}], 'interventions': [{'name': 'insulin infusion', 'type': 'DRUG', 'otherNames': ['Intravenous regular insulin infusion'], 'description': 'insulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl', 'armGroupLabels': ['Normal weight subjects', 'obese subjects', 'obese type 2 diabetes subjects']}, {'name': 'Dextrose infusion', 'type': 'DRUG', 'otherNames': ['Intravenous dextrose solution infusion'], 'description': 'Dextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl', 'armGroupLabels': ['Normal weight subjects', 'obese subjects', 'obese type 2 diabetes subjects']}, {'name': 'Saline Infusion', 'type': 'DRUG', 'otherNames': ['normal saline infusion'], 'description': 'Saline will be infused at 100ml/hr', 'armGroupLabels': ['Normal weight subjects', 'obese subjects', 'obese type 2 diabetes subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Millard Fillmore Gates Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Paresh Dandona, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Research foundation of SUNY at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'University at Buffalo'}}}}