| Trial ID: | L6689 |
| Source ID: | NCT02299388
|
| Associated Drug: |
Liraglutide Or Placebo
|
| Title: |
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02299388/results
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| Conditions: |
Diabetes Mellitus, Non-Insulin-Dependent|Hypertensive Disease
|
| Interventions: |
DRUG: Liraglutide or Placebo
|
| Outcome Measures: |
Primary: Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors., To determine whether Liraglutide lowers systolic BP through the day compared to placebo in patients with T2DM who are not on any anti-hypertensive medications or whose BP medications are unchanged over the study period of 8 weeks., Baseline and 8 Weeks | Secondary: Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures., 1. Change in mean arterial blood pressure and diastolic blood pressure from baseline to 8 weeks in the intent-to-treat (ITT) population. 2. Change in nocturnal BP: the absence of the nocturnal (between 23:00-06:00 hrs) decline in BP of \>/= 10% (defined as "non-dippers") and whether restoration occurs following Liraglutide therapy. 3. Change in pulse pressure: defined as the difference in systolic and diastolic BPs from baseline to week 8., Baseline and 8 Weeks | Other: Change in Endothelial Function. (Using Endo PAT), To understand the BP lowering effect of Liraglutide, the investigators will study the Endothelial function - using Endo PAT, Baseline and 8 Weeks|Change in Autonomic Function (Heart Rate Variability Using Endo PAT.), To understand the BP lowering effect of Liraglutide, the investigators will study the the autonomic function by assessing the heart rate variability using Endo PAT., Baseline and 8 Weeks|Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels), To understand the mechanisms of BP lowering effect of Liraglutide, the investigators will study the effects on Renin Angiotensin system by measuring Plasma renin and aldosterone levels and Urine Angiotensinogen levels (U-AGT-using an assay developed at Tulane Hypertension Center)., Baseline and 8 Weeks|Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.), To understand the BP lowering effect of Liraglutide, the investigators will analyse the catecholamines by collecting 24 hrs urine for metanephrines and catecholamines., Baseline and 8 Weeks|Change in Urinary Sodium Excretion, To understand the BP lowering effect of Liraglutide, the investigators will assess urinary sodium excretion by collecting 24 hours Urine Sodium., Baseline and 8 Weeks
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| Sponsor/Collaborators: |
Sponsor: Tulane University School of Medicine | Collaborators: Novo Nordisk A/S
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-10
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| Completion Date: |
2016-12
|
| Results First Posted: |
2019-05-08
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| Last Update Posted: |
2021-01-27
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| Locations: |
Tulane University Health Science Center, Tidewater building and Tulane Hospital and Clinics, New Orleans, Louisiana, 70112, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02299388
|
