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

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent
• Hypertensive Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Liraglutide or Placebo — DRUG
  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.

Study Details

The investigators are conducting this research to study the effect of Liraglutide on blood pressure. Several studies have shown increased cardiovascular complications and deaths in diabetics with hypertension. The importance of blood pressure control in diabetes has been shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus is known to reduce blood pressure along with improving diabetes. However, prior research studies with liraglutide have suggested that treatment with liraglutide improves blood pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism behind this effect is yet to be determined.

Key Dates

Start date

Oct 31, 2014

Status verified

Jan 2021

Primary completion

Nov 30, 2016

Completion

Dec 31, 2016

Study Design

Enrollment

11 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors. [ Time Frame: Baseline and 8 Weeks ]

Locations (1)

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