| Trial ID: | L4563 |
| Source ID: | NCT00925119
|
| Associated Drug: |
Atenolol
|
| Title: |
Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
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| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00925119/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Atenolol
|
| Outcome Measures: |
Primary: Change in Diastolic Function (Annular Tissue Velocity [Em]), 8 weeks|Change in Free Fatty Acid Kinetics, Estimate of peripheral lipolysis using modeling of free fatty acid levels collected during an IV glucose tolerance test. The change in threshold for insulin action (post-atenolol minus pre-atenolol) is the primary variable from this modeling that we analyzed., Baseline and Week 8 | Secondary: Change in Triglycerides, (Post atenolol triglycerides - Pre atenolol triglycerides), Baseline and Week 8|Change in Insulin Sensitivity, As measured by the Homeostatic model assessment of insulin resistance (HOMA2-IR) (post atenolol - pre atenolol). he Homeostatic model assessment (HOMA) is a method for assessing insulin sensitivity from fasting glucose and insulin. A higher HOMA value indicates higher insulin resistance. The widely-used formulae available for HOMA1 provide only linear approximations of HOMA_%B and HOMA_IR, the inverse of HOMA_%S. These are: HOMA1_IR = \[FPI (uU/ml) x FPG (mmol/l) \]/22.5 HOMA1_%B = (20 x FPI)/(FPG - 3.5) The results obtained for HOMA2 may differ considerably from HOMA1 computer-calculated values, especially for more extreme glucose and insulin values. For this reason, no attempt has been made to provide linear approximations of HOMA2 calculated values of HOMA_%B, HOMA_IR and HOMA_%S. The software needed to calculate HOMA2 values is available on this website: https://www.dtu.ox.ac.uk/homacalculator/download.php, subject to the conditions specified on the downloads page., Baseline and Week 8|Change in Glucose Effectiveness, Glucose effectiveness as measured by insulin-modified IV glucose tolerance test using the MINMOD model., Baseline and Week 8|Change in HDL, Baseline and Week 8|Change in Insulin, fasting insulin (post - pre atenolol), Baseline and Week 8
|
| Sponsor/Collaborators: |
Sponsor: University of Maryland, Baltimore | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-12
|
| Completion Date: |
2014-05
|
| Results First Posted: |
2017-12-22
|
| Last Update Posted: |
2019-09-26
|
| Locations: |
University of Maryland, Baltimore, Maryland, 21201, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00925119
|
