The Effect of Linagliptin on Mitochondrial and Endothelial Function

PHASE4CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Type II Diabetes Mellitus
Interventions
DRUG

Linagliptin

DRUG

Placebo

OTHER

Microcirculation testing

The endothelial function of the micro-circulation will be assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.

OTHER

Macrocirculation testing

Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodilation).

OTHER

MRI Scans

Phosphorus-31 MRI data will be obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia.

Trial Locations (1)

02215

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
lead

Beth Israel Deaconess Medical Center

OTHER

NCT01969084 - The Effect of Linagliptin on Mitochondrial and Endothelial Function | Biotech Hunter | Biotech Hunter