- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299388
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Science Center, Tidewater building and Tulane Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.
- HbA1c>7% and ≤10.5% at randomization.
- Men and women of 18-75 years of age.
- Women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. A urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. If positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.
- Blood pressure≥ 130/80 mm Hg and ≤160/100mmHg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. No change in treatment for BP over 8 weeks of the study will be allowed.
- Patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.
Exclusion Criteria:
1. Type 1 diabetes and/or history of ketoacidosis determined by medical history.
2. History of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
3. Therapy with DPP-4 inhibitor, or GLP -1 analog or receptor agonist in the past 6 months.
4. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
5. Patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (>2 weeks).
6. Use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
7. Surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.
8. Serum creatinine >1.4mg/dL (women)/>1.5mg/dL (men). 9. Serum Triglyceride Level >500 mg/dL. 10. History of pancreatitis. 11. History of drug or alcohol abuse. 12. Poor mental function or any reason to expect patient difficulty in complying with study requirements.
13. Contraindications to Liraglutide: Personal or family history of medullary thyroid cancer or MEN-2 syndrome 14. Known or suspected allergy to Liraglutide. 15. Diagnosed Secondary hypertension.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
Time Frame: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Time Frame: Baseline and 8 Weeks
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Baseline and 8 Weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Endothelial Function. (Using Endo PAT)
Time Frame: Baseline and 8 Weeks
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To understand the BP lowering effect of Liraglutide, the investigators will study the Endothelial function - using Endo PAT
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Baseline and 8 Weeks
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Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)
Time Frame: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)
Time Frame: Baseline and 8 Weeks
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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).
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Baseline and 8 Weeks
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Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)
Time Frame: Baseline and 8 Weeks
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To understand the BP lowering effect of Liraglutide, the investigators will analyse the catecholamines by collecting 24 hrs urine for metanephrines and catecholamines.
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Baseline and 8 Weeks
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Change in Urinary Sodium Excretion
Time Frame: Baseline and 8 Weeks
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To understand the BP lowering effect of Liraglutide, the investigators will assess urinary sodium excretion by collecting 24 hours Urine Sodium.
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Baseline and 8 Weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hypertension
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Liraglutide
Other Study ID Numbers
- 523963-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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