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Clinical Trial Details

Trial ID: L5073
Source ID: NCT02544321
Associated Drug: Bromocriptine
Title: Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02544321/results
Conditions: Type 1 Diabetes
Interventions: DRUG: Bromocriptine|OTHER: Placebo
Outcome Measures: Primary: Mean Glucose, At the end of each 4 week intervention period, we will measure the effect of Bromocriptine Quick Release on average glucose levels (mg/dl) by continuous glucose monitoring, 4 weeks|Insulin Dosing, At the end of each 4 week intervention period, we will measure the effect of BCQR on insulin dosing (units//kg/day), 4 weeks|Brachial Artery Distensibility, At the end of each 4 week intervention period, we will measure the brachial artery distensibility as a measure of vascular stiffness by Dynapulse (%/mmHg). A larger number indicates less stiffness (ie greater compliance)., 4 weeks|Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI), At the end of each 4 week intervention period, we will measure the reactive hyperemia Index (RHI). The Reactive Hyperemia Index (RHI) measures increased bloodflow after vascular occlusion. Higher scores indicate lower CVD risk and a better outcome, Scores of less than 1.67 may be considered abnormal. Scores of 1.67 1.67-2.09 may be considered borderline, and scores of 2.10 or higher my be considered normal., 4 weeks | Secondary: Mean Glycemic Variability, At the end of each 4 week intervention period, we will measure the effect of Bromocriptine Quick Release on glycemic variability throughout the day (mg/dl), measured as SD of all glucose values throughout the last 7 days of intervention. Incorrectly initially entered as primary outcome. per protocol this has always been a secondary outcome., 4 weeks|Hypoglycemia Awareness, At the end of each 4 week intervention period, we will measure Hypoglycemia Awareness using the Gold method (7 point Likert scale: Possible scores range from 1 to 7. higher scores indicate more impaired awareness of hypoglycemia, and a worse outcome), Clarke method (8 question questionnaire characterizing hypoglycemia awareness. Possible scores range from 0-7, with higher scores indicating less awareness and a worse outcome), and the McAuley score (list of symptoms with a 7 point Likert scale for each. Possible scores range from 1-7 for each item, and are averaged across all symptoms, for a total possible score range of 1-7, with higher scores indicating more symptom awareness, and a better outcome). Incorrectly initially entered as primary outcome. per protocol this has always been a secondary outcome., 4 weeks|Augmentation Index, At the end of each 4 week intervention period, the % will be measured by SyphgmoCor. The Augmentation Index measures vascular stiffness by comparing pulse pressure of the reflected wave to the primary wave. HIGHER scores indicate greater vascular stiffness and higher cardiovascular risk, but a normal range has not been clearly defined. Presented as AI normalized to a heart rate of 75 (AI75)., 4 weeks|Heart Rate Variability (Adults), At the end of each 4 week intervention period we will measure the autonomic function by ECG. Ratio of maximum heart rate/minimum heartrate during a valsalva maneuver., 4 weeks|Heart Rate Variability (Adolescents), At the end of each 4 week intervention period we will measure the autonomic function by HRV measured by endopat and reported using the single gold standard measure of SDNN (standard deviation of beat to beat time interval). Normal is \>100, 50-100 indicates compromised autonomic function., 4 weeks|Sleep Duration, At the end of each 4 week intervention period, measurements of sleep duration on weekdays and weekends (minutes) by a Philips Spectrum Plus sleep monitor will be obtained., 4 weeks|Sleep Quality, At the end of each 4 week intervention period, measurements of sleep efficiency (percent of time in bed spent asleep) during the week and on weekends by a Philips Spectrum Plus sleep monitor will be obtained., 4 weeks|Metabolic Markers-glucose and Triglycerides, At the end of each 4 week intervention period, glucose, insulin, triglycerides, NEFA, GLP-1, and glucagon area under the curve will be measured during Mixed Meal Tolerance Test., 4 weeks|Metabolic Markers-fatty Acids, At the end of each 4 week intervention period, glucose, insulin, triglycerides, NEFA, GLP-1, and glucagon area under the curve will be measured during Mixed Meal Tolerance Test., 4 weeks|Metabolic Markers-glucagon, At the end of each 4 week intervention period, glucose, insulin, triglycerides, NEFA, GLP-1, and glucagon area under the curve will be measured during Mixed Meal Tolerance Test., 4 weeks|Metabolic Markers - GLP1, At the end of each 4 week intervention period, glucose, insulin, triglycerides, NEFA, GLP-1, and glucagon area under the curve will be measured during Mixed Meal Tolerance Test., 4 weeks|Metabolic Markers - Insulin, At the end of each 4 week intervention period, glucose, insulin, triglycerides, NEFA, GLP-1, and glucagon area under the curve will be measured during Mixed Meal Tolerance Test., 4 weeks
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2019-06
Results First Posted: 2021-09-13
Last Update Posted: 2021-09-13
Locations: University of Colorado-Denver, Anshutz Medical Campus, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT02544321