| Trial ID: | L5136 |
| Source ID: | NCT00153179
|
| Associated Drug: |
Acipimox
|
| Title: |
Free Fatty Acids and Vascular Function in Subjects With Diabetes
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00153179/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: acipimox|DRUG: placebo
|
| Outcome Measures: |
Primary: Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome, Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation., 7 days|Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo, Insulin sensitivity (M) is measured by using a hyperinsulinaemic-euglycaemic clamp. Insulin sensitivity (M) was calculated as the average glucose infusion rate (mg/kg of body weight per min) over the last 30 min of the clamp. Higher values indicate better outcomes (more insulin sensitive), while lower values indicate more insulin resistance., baseline, 7 days |
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2005-09
|
| Completion Date: |
2013-03
|
| Results First Posted: |
2013-07-08
|
| Last Update Posted: |
2018-09-25
|
| Locations: |
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00153179
|
