{"protocolSection":{"identificationModule":{"nctId":"NCT01791465","orgStudyIdInfo":{"id":"121342"},"secondaryIdInfos":[{"id":"P30AI054999","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P30AI054999"}],"organization":{"fullName":"Vanderbilt University Medical Center","class":"OTHER"},"briefTitle":"Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults","officialTitle":"Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"TERMINATED","whyStopped":"This study was terminated after 6 patients due to loss of funding","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-03"},"primaryCompletionDateStruct":{"date":"2014-12","type":"ACTUAL"},"completionDateStruct":{"date":"2014-12","type":"ACTUAL"},"studyFirstSubmitDate":"2013-02-11","studyFirstSubmitQcDate":"2013-02-13","studyFirstPostDateStruct":{"date":"2013-02-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-05-05","resultsFirstSubmitQcDate":"2017-01-20","resultsFirstPostDateStruct":{"date":"2017-03-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-01-20","lastUpdatePostDateStruct":{"date":"2017-03-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"John R. Koethe","investigatorTitle":"Assistant Professor of Medicine","investigatorAffiliation":"Vanderbilt University"},"leadSponsor":{"name":"Vanderbilt University","class":"OTHER"},"collaborators":[{"name":"National Institute of Allergy and Infectious Diseases (NIAID)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated diabetes mellitus. Previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in HIV-infected adults. The Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated adults.","detailedDescription":"No further information. This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. The primary endpoint assessed whether the intervention reduced inflammation. There was no control arm."},"conditionsModule":{"conditions":["Human Immunodeficiency Virus Infection","Diabetes Mellitus"],"keywords":["HIV","Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":6,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bydureon treatment","type":"EXPERIMENTAL","description":"Treatment for 16 weeks with extended-release Exenatide (Bydureon)","interventionNames":["Drug: extended-release exenatide"]}],"interventions":[{"type":"DRUG","name":"extended-release exenatide","description":"Single arm study - 2mg Bydureon every 7 days x 16 weeks","armGroupLabels":["Bydureon treatment"],"otherNames":["Bydureon"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks","description":"The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks","description":"The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.","timeFrame":"baseline and 16 weeks"}],"secondaryOutcomes":[{"measure":"Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks","description":"The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance.","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Adipokine Leptin Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Body Mass Index at Baseline and 16 Weeks","timeFrame":"16 weeks"},{"measure":"Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Soluble CD14 Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Triglycerides Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum Total Cholesterol Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum HDL Cholesterol Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Serum LDL Cholesterol Levels at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Body Weight at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Waist Circumference at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Hip Circumference at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"},{"measure":"Waist to Hip Ratio at Baseline and 16 Weeks","timeFrame":"baseline and 16 weeks"}],"otherOutcomes":[{"measure":"Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks","description":"Normal: LnRHI \\> 0.51 Abnormal: LnRHI ≤ 0.51","timeFrame":"baseline and 16 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Body mass index ≥ 25 kg/m2\n* Glycosylated hemoglobin (A1C) value ≥ 6.5% OR having a fasting blood glucose ≥ 126 mg/dL\n* On stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma HIV-1 RNA level)\n* Negative serum pregnancy test (females only)\n\nExclusion Criteria:\n\n* History of pancreatitis\n* Screening serum lipase value greater than or equal to 2 times the upper limit of normal (≥ 420 U/L)\n* History of pancreatic cancer or thyroid cancer in patient, a first-degree relative, or a grandparent\n* History of Multiple Endocrine Neoplasia (MEN) 2 syndrome\n* History of gastroparesis, inflammatory bowel disease, and/or other severe gastrointestinal disease\n* Estimated glomerular filtration rate (eGFR) ≤ 50 mls/minute\n* Documented history of hypoglycemia (blood glucose \\<40 mg/dl)\n* Active moderate-heavy alcohol use (more than 2 drinks/day) or \\>4 drinks in a single 24 hour period\n* On an anti-diabetic medication within 3 months of enrollment\n* On an HMG-CoA reductase inhibitor (statin) within 3 months of enrollment\n* Persons on a didanosine (ddI) and/or stavudine (d4T)-containing cART (due to the heightened risk of pancreatitis)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"99 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"John Koethe, MD","affiliation":"Vanderbilt University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"},{"name":"C. William Wester, MD","affiliation":"Vanderbilt University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","zip":"37240","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"No consented participants were excluded prior to group assignment","recruitmentDetails":"Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.","groups":[{"id":"FG000","title":"Bydureon Treatment","description":"Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bydureon Treatment","description":"Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51","lowerLimit":"45","upperLimit":"70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks","description":"The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.","populationDescription":"Change in hsCRP over 16 weeks of treatment","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dl","timeFrame":"baseline and 16 weeks","groups":[{"id":"OG000","title":"Bydureon Treatment","description":"Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. 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