Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 396 for:    LIRAGLUTIDE

To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299388
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Tina K. Thethi, Tulane University Health Sciences Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Non-Insulin-Dependent
Hypertensive Disease
Intervention Drug: Liraglutide or Placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

Period Title: Overall Study
Started 6 5
Completed 6 4
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Liraglutide Placebo Total
Hide Arm/Group Description

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
3
  60.0%
8
  72.7%
>=65 years
1
  16.7%
2
  40.0%
3
  27.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
57.67
(43 to 68)
59.8
(54 to 66)
58.64
(43 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
3
  50.0%
5
 100.0%
8
  72.7%
Male
3
  50.0%
0
   0.0%
3
  27.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
5
 100.0%
11
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  50.0%
5
 100.0%
8
  72.7%
White
3
  50.0%
0
   0.0%
3
  27.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6
 100.0%
5
 100.0%
11
 100.0%
1.Primary Outcome
Title Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
Hide Description 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.
Time Frame Baseline and 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects in the placebo group completed 80% ambulatory blood pressure measurements at visits 2 (baseline) and visit 5 (8 weeks).
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

Overall Number of Participants Analyzed 6 2
Mean (Full Range)
Unit of Measure: mm/Hg
-4.88
(-18.6 to 13.6)
-5.45
(-6.9 to -4.0)
2.Secondary Outcome
Title Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Hide Description
  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.
Time Frame Baseline and 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects in the placebo group completed 80% ambulatory blood pressure measurements at visits 2 (baseline) and visit 5 (8 weeks). One placebo subject did not have an overall pulse pressure value at week 8 and was eliminated from that outcome analysis.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

Overall Number of Participants Analyzed 6 2
Mean (Full Range)
Unit of Measure: mm/Hg
Overall Systolic Pressure Number Analyzed 6 participants 2 participants
-4.4
(-18.5 to 11.8)
-5.4
(-9.4 to -1.4)
Overall Diastolic Pressure Number Analyzed 6 participants 2 participants
-1.8
(-7.5 to 9.5)
-3.3
(-9.8 to 3.2)
Overall Pulse Pressure Number Analyzed 6 participants 1 participants
-2.7
(-11 to 1.4)
0.4
(0.4 to 0.4)
Mean Arterial Pressure Number Analyzed 6 participants 2 participants
-2.6
(-11.2 to 10.3)
-4
(-9.7 to 1.7)
Nocturnal Systolic Pressure Number Analyzed 6 participants 2 participants
1.15
(-18.5 to 14.7)
-2.3
(-25.3 to 20.6)
Nocturnal Diastolic Pressure Number Analyzed 6 participants 2 participants
1.0
(-12.1 to 19)
-0.8
(-14 to 12.5)
3.Other Pre-specified Outcome
Title Change in Endothelial Function. (Using Endo PAT)
Hide Description To understand the BP lowering effect of Liraglutide, the investigators will study the Endothelial function - using Endo PAT
Time Frame Baseline and 8 Weeks
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)
Hide Description 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.
Time Frame Baseline and 8 Weeks
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)
Hide Description 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).
Time Frame Baseline and 8 Weeks
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)
Hide Description To understand the BP lowering effect of Liraglutide, the investigators will analyse the catecholamines by collecting 24 hrs urine for metanephrines and catecholamines.
Time Frame Baseline and 8 Weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Change in Urinary Sodium Excretion
Hide Description To understand the BP lowering effect of Liraglutide, the investigators will assess urinary sodium excretion by collecting 24 hours Urine Sodium.
Time Frame Baseline and 8 Weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Liraglutide or Placebo: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

All-Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tina Thethi
Organization: Tulane University
Phone: 504-988-5044
EMail: tthethi@tulane.edu
Layout table for additonal information
Responsible Party: Tina K. Thethi, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02299388     History of Changes
Other Study ID Numbers: 523963-1
First Submitted: February 4, 2014
First Posted: November 24, 2014
Results First Submitted: April 26, 2018
Results First Posted: May 8, 2019
Last Update Posted: May 8, 2019