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

This study is currently recruiting participants.
Verified December 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01046721
First received: January 11, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  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:

Drug Information available for: Exenatide
U.S. FDA Resources

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 ]

Estimated Enrollment: 12
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated 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% NaCl solution (0.02 ml)
 Drug: Saline
subcutaneous administration of 0.9% NaCl 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046721

Contacts
Contact: Buddhike Mendis, MRCP 011599249924 ext 63388 mbxbm@nottingham.ac.uk
Contact: Peter mansell, FRCP 01159249924 peter.mansell@nuh.nhs.uk

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

No publications provided

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: December 3, 2012
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

ClinicalTrials.gov processed this record on May 19, 2013