Trial Outcomes & Findings for To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study (NCT NCT02299388)
NCT ID: NCT02299388
Last Updated: 2021-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
Baseline and 8 Weeks
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Liraglutide
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.
|
Placebo
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 Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Liraglutide
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.
|
Placebo
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 Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
Baseline characteristics by cohort
| Measure |
Liraglutide
n=6 Participants
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.
|
Placebo
n=5 Participants
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
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
57.67 years
n=5 Participants
|
59.8 years
n=7 Participants
|
58.64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 WeeksPopulation: Only 2 subjects in the placebo group completed 80% ambulatory blood pressure measurements at visits 2 (baseline) and visit 5 (8 weeks).
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.
Outcome measures
| Measure |
Liraglutide
n=6 Participants
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.
|
Placebo
n=2 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
|
-4.88 mm/Hg
Interval -18.6 to 13.6
|
-5.45 mm/Hg
Interval -6.9 to -4.0
|
SECONDARY outcome
Timeframe: Baseline and 8 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Liraglutide
n=6 Participants
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.
|
Placebo
n=2 Participants
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.
|
|---|---|---|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Overall Systolic Pressure
|
-4.4 mm/Hg
Interval -18.5 to 11.8
|
-5.4 mm/Hg
Interval -9.4 to -1.4
|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Overall Diastolic Pressure
|
-1.8 mm/Hg
Interval -7.5 to 9.5
|
-3.3 mm/Hg
Interval -9.8 to 3.2
|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Overall Pulse Pressure
|
-2.7 mm/Hg
Interval -11.0 to 1.4
|
0.4 mm/Hg
Interval 0.4 to 0.4
|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Mean Arterial Pressure
|
-2.6 mm/Hg
Interval -11.2 to 10.3
|
-4 mm/Hg
Interval -9.7 to 1.7
|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Nocturnal Systolic Pressure
|
1.15 mm/Hg
Interval -18.5 to 14.7
|
-2.3 mm/Hg
Interval -25.3 to 20.6
|
|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Nocturnal Diastolic Pressure
|
1.0 mm/Hg
Interval -12.1 to 19.0
|
-0.8 mm/Hg
Interval -14.0 to 12.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 WeeksTo understand the BP lowering effect of Liraglutide, the investigators will study the Endothelial function - using Endo PAT
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 WeeksTo understand the BP lowering effect of Liraglutide, the investigators will study the the autonomic function by assessing the heart rate variability using Endo PAT.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 WeeksTo 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 WeeksTo understand the BP lowering effect of Liraglutide, the investigators will analyse the catecholamines by collecting 24 hrs urine for metanephrines and catecholamines.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 WeeksTo understand the BP lowering effect of Liraglutide, the investigators will assess urinary sodium excretion by collecting 24 hours Urine Sodium.
Outcome measures
Outcome data not reported
Adverse Events
Liraglutide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place