Clinical Trial Details
| Trial ID: | L2204 |
| Source ID: | NCT02372630 |
| Associated Drug: | Linagliptin |
| Title: | The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects |
| Acronym: | 1971 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02372630/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Linagliptin|DRUG: Placebo |
| Outcome Measures: | Primary: JNK-1 Protein in MNC, JNK-1 protein in MNC before and after linagliptin use as compared to placebo., Week 0, Week 2, Week 4, Week 12 | Secondary: IL-1β mRNA Levels, Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12., Week 0, Week 2, Week 4, Week 12|Oxidative Stress (as ROS Generation Level), oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells, Week 0, Week 2, Week 4, Week 12|Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp, Insulin sensitivity is measured with HE clamp. Glucose Infusion Rate was titrated to maintain blood glucose concentration at the fasting glucose level. Plasma samples for glucose was obtained at 10-minute intervals starting 30 minutes before the clamp, to quantitate rates of whole-body glucose disposal. Difference from baseline at 12 weeks is calculated and compared to placebo arm, At baseline and week 12 |
| Sponsor/Collaborators: | Sponsor: University at Buffalo | Collaborators: Kaleida Health |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 40 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-05-23 |
| Completion Date: | 2018-05-01 |
| Results First Posted: | 2023-02-21 |
| Last Update Posted: | 2023-02-21 |
| Locations: | ECMC Ambulatory Center, 3rd Floor, Buffalo, New York, 14215, United States |
| URL: | https://clinicaltrials.gov/show/NCT02372630 |
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