| Trial ID: | L5325 |
| Source ID: | NCT00753142
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| Associated Drug: |
Intralipid 20%
|
| Title: |
Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00753142/results
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| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Intralipid 20%|DRUG: Glucose infusion
|
| Outcome Measures: |
Primary: First-Phase Insulin Release (FPIR), An arginine stimulation test was used to evaluate beta-cell function and insulin secretion. Increased glucose in the blood causes insulin to be released, beginning with a spike in insulin in the first 10 minutes and plateauing 2 to 3 later. Diminished first-phase insulin release is an early indicator of beta-cell dysfunction. Two sequential arginine stimulation tests were performed, the first set before and the second after completion of the 20-hour dextrose infusion. The first-phase insulin release (FPIR) was calculated as the sum of the insulin levels at 2, 3, 4, and 5 minutes after the arginine infusion. FPIR is expected to rise after the dextrose (glucose) infusion and FPIR generally rises less in persons with impaired glucose tolerance., Hour 0, Hour 20 | Secondary: Number of Participants With Beta-cell Failure, Pancreatic beta-cells can adapt to insulin resistance during the early stages of diabetes but continuous exposure of beta-cells to prolonged hyperglycemia can cause irreversible damage due to glucotoxicity. This study aimed to evaluate whether hyperglycemia-induced reduced beta-cell failure was the result of beta-cell exhaustion or beta-cell desensitization, however, no participants experienced beta-cell failure so this original analysis could not be performed., Hour 20
|
| Sponsor/Collaborators: |
Sponsor: Emory University | Collaborators: American Diabetes Association
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
28
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-03
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| Completion Date: |
2009-12
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| Results First Posted: |
2014-08-01
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| Last Update Posted: |
2018-10-12
|
| Locations: |
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00753142
|
