Study Looking at Cardiovascular Effects of Exenatide, Its Blood Pressure Lowering Effect and Its Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01046721
First received: January 11, 2010
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

Exenatide is a new drug which lowers blood sugar (glucose) levels for people with type 2 diabetes. It has significant advantages over other treatments such as insulin as it causes weight loss in a group of people that is generally overweight. Data from studies involving exenatide have shown that it also has an effect on blood pressure. The mechanism for the blood pressure lowering effect is not known and has not been investigated previously. Exenatide may have an effect on blood vessels throughout the body and gut to reduce blood pressure. 12 healthy men (18-45yr) will be studied on 2 occasions. Limb blood flow, skin blood flow, gut blood flow, blood pressure, and heart rate will be measured half hourly for 4 hours. Blood samples (3ml) for insulin and glucose determination will be taken via a cannula and 3-way tap at the same time points. A dose of either 5μg exenatide or saline will be injected under the skin of the abdomen and a breakfast will be provided during the study. A urine collection will be made over the duration of the study.


Condition Intervention
Type 2 Diabetes
Drug: Exenatide
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Cardiovascular Effects of Exenatide in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Meal induced changes in superior mesenteric (SMA) blood flow - exenatide versus placebo. [ Time Frame: 0, 30, 60, 90, 120, 150, & 180 min after meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary: BP, HR, Limb Blood Flow, Skin Blood Flow, peripheral resistance responses when fasted and after eating- Exenatide vs. placebo. [ Time Frame: 0, 30, 60, 90, 120, 150, & 180 min after meal ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exenatide
subcutaneous administration of Exenatide (0.02ml)
Drug: Exenatide
single dose of 5 microg Exenatide. Subcutaneous administration
Other Name: Byetta
Placebo Comparator: 0.9% Saline
subcutaneous administration of 0.9% saline solution (0.02 ml)
Drug: Saline
subcutaneous administration of 0.9% saline solution (0.02 ml)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male,
  • non-obese (BMI 20-27: those with a BMI > 25 will be excluded if they have a waist circumference > 90cm),
  • aged 18-45yrs,
  • non-smoker.

Exclusion Criteria:

  • any metabolic or endocrine abnormalities,
  • clinically significant abnormalities on screening,
  • taking regular medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046721

Locations
United Kingdom
David Greenfield Human Physiology Laboratories
Nottingham, Notts, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Peter I Mansell, FRCP University of Nottingham
  More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01046721     History of Changes
Other Study ID Numbers: A/6/2009-exenatide-CVS
Study First Received: January 11, 2010
Last Updated: August 20, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
blood pressure
superior mesenteric artery blood flow
cardiovascular effects
Exenatide

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014