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

NCT02299388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-01-27

Study results available
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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.

Conditions

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Tulane University School of Medicine

    lead OTHER

Principal Investigators

  • Tina Thethi, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02299388 on ClinicalTrials.gov