To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hypertensive Disease
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      Blood pressure will be monitored using the 24 hour Ambulatory Blood Pressure monitor: a
      device that monitors your blood pressure while you continue normal activity. We have chosen
      this method to monitor blood pressure because most of the prior studies have proven it to be
      superior over a single blood pressure recording and its ability to better predict clinical
      outcomes.

      It is well known that both diabetes and hypertension cause endothelial dysfunction.
      Endothelium is the inner lining of the blood vessels. When it is functioning, it is supposed
      to regulate blood clotting, help with the body's immune response, controls the volume of
      fluid and other substances that pass through the blood vessels. Hence, normal endothelial
      function protects the blood vessels from atherosclerosis (hardening) and builds up of plaque.
      When it is not functioning well (as in diabetes, hypertension, cigarette smokers etc.) it
      does not perform one or more of these functions. Hence, in this study, we will also measure
      the endothelial function using a machine: ENDO PAT.

      This is a non-invasive diagnostic test which is done in the doctor's office. Usually takes
      about 15 minutes. It is not painful. It generates an EndoScore which indicates the current
      state of the endothelial health.

      This is a PILOT study (a small-scale study designed to determine if a larger, full-scale
      study is doable) to prove this effect which if proven will be extended to a larger,
      multicenter trial.

      Of note: Liraglutide has already been approved for treating Type 2 Diabetes Mellitus.
    

Intervention name(s): Liraglutide or Placebo
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Hypertension; ambulatory blood pressure monitoring; Endothelial Dysfunction; Pulse pressure; Renin-angiotensin system; heart rate variability