| Trial ID: | L4812 |
| Source ID: | NCT04146155
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| Associated Drug: |
Liraglutide+Standard-Of-Care Treatment
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| Title: |
Efficacy and Safety of Liraglutide in Type 2 Diabetes With Lower Extremity Arterial Disease
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| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes|Peripheral Vascular Disorder Due to Diabetes Mellitus
|
| Interventions: |
DRUG: Liraglutide+standard-of-care treatment|OTHER: standard-of-care treatment
|
| Outcome Measures: |
Primary: Initial and absolute claudication distance, The primary outcome measures used to assess efficacy were pain-free walking distance (distance walked to the onset of symptoms, or the initial claudication distance \[ICD\]) and the maximum distance walked (absolute claudication distance \[ACD\]) on standardized treadmill testing. Evaluation of walking performance was accomplished with standardized treadmill testing. A constant speed of 3.2 km/h (2mile/h) and a fixed incline of 12.5% were used., 24 weeks | Secondary: Assess the effects on ABI of a six month treatment with Liraglutide compared to control group (standard-of-care treatment)., ankle-brachial index is ratio of ankle systolic pressure to arm systolic pressure: using a 10-12 cm sphygmomanometer cuff placed just above the ankle and a doppler instrument used to measure the systolic pressure of the posterior tibial and dorsalis pedis arteries of each leg. These pressures are then normalized to the higher brachial pressure of either arm to form the ankle-brachial index (ABI). The index leg is often defined as the leg with the lower ABI., 24 weeks|Assess the effects on endothelial function of a six month treatment with Liraglutide compared to control group (standard-of-care treatment)., Assess the effects on endothelial function of a six month treatment with Liraglutide compared to conventional treatment, assessed as the baseline corrected change in endothelial function by flow-mediated vasodilation (FMD) of the brachial artery at 6 months., 24 weeks|Muscle microvascular perfusion by CEU, Contrast enhanced ultrasound (CEU) performed by experienced radiologists is used for contrast ultrasonographic examination of skeletal muscle., 24 weeks|Assess the effects on the endothelial circulating progenitor cells concentration of a six month treatment with Liraglutide compared to control group (standard-of-care treatment)., Circulating progenitor cells (EPCs) will be quantified using flow cytometry before and after 6 month treatment GLP-1 receptor agonist or conventional therapy (control group). Briefly, after erythrocyte lysis, peripheral blood will be stained with 10µL fluorescein isothiocyanate-conjugated anti-human CD34 mAb, 10µL phycoethrin-conjugated anti-human KDR mAb, and 10µL allophycocyanin-conjugated anti-CD133 mAb., 24 weeks|Changes from baseline in HbA1c, Change from baseline to last assessment during the treatment period in HbA1c, 24 weeks
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| Sponsor/Collaborators: |
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-05-01
|
| Completion Date: |
2021-12-31
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| Results First Posted: |
|
| Last Update Posted: |
2021-07-07
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| Locations: |
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04146155
|
