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NCT01969084 · ClinicalTrials.gov registry record · Phase 4
The Effect of Linagliptin on Mitochondrial and Endothelial Function
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT01969084 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 45 participants.
The verdict
NCT01969084, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, increase the blood flow at the muscle microcirculation level and improve mitochondrial function. In this study, investigators will perform tests that evaluate the function of small and large blood vessels by employing ultrasound and laser doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the lower extremity muscles at rest and during exercise will also be employed. Forty subjects with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly assigned to receive linagliptin while the other half will receive placebo. All tests will be performed at the beginning and the end of the study.
Interventions
- DRUG Placebo
- DRUG Linagliptin
- OTHER Microcirculation testing
- OTHER Macrocirculation testing
- OTHER MRI Scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01969084
The ClinicalTrials.gov registry entry for NCT01969084 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01969084 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01969084 about?
NCT01969084 is a clinical study titled "The Effect of Linagliptin on Mitochondrial and Endothelial Function". Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, incr...
What is the current status of trial NCT01969084?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2013-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01969084?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG), Microcirculation testing (OTHER), Macrocirculation testing (OTHER), MRI Scans (OTHER).
Who is sponsoring clinical trial NCT01969084?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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