| Trial ID: | L5175 |
| Source ID: | NCT00775684
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| Associated Drug: |
Exenatide
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| Title: |
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00775684/results
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| Conditions: |
Pre-diabetes|Type 2 Diabetes
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| Interventions: |
DRUG: Exenatide|DRUG: Sitagliptin|DRUG: Glimepiride
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| Outcome Measures: |
Primary: Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml), The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups, Baseline and 6 months|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL), AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups., Baseline and 6 months | Secondary: Change in Acute Insulin Response to Arginine. (AIRarg), The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group., Baseline and 6 months|Insulin Sensitivity at Baseline and 6 Months, Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared, Baseline and 6 months|PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months, Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24-26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months., Baseline and 6 months
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| Sponsor/Collaborators: |
Sponsor: University of Pennsylvania | Collaborators: Pennsylvania Department of Health
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
47
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2008-10
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| Completion Date: |
2012-11
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| Results First Posted: |
2017-12-06
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| Last Update Posted: |
2022-06-07
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| Locations: |
Clinical and Translational Research Center, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Rodebaugh Diabetes Center, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Pennsylvania Hospital, Philadelphia, Pennsylvania, 19107, United States
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| URL: |
https://clinicaltrials.gov/show/NCT00775684
|
