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

This study has been completed.
Information provided by (Responsible Party):
University of Nottingham Identifier:
First received: January 11, 2010
Last updated: April 26, 2016
Last verified: April 2016
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 (Participant, 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 ]

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 ]

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)
Other Name: 0.9% Saline solution

  Show Detailed Description


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01046721

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

Responsible Party: University of Nottingham Identifier: NCT01046721     History of Changes
Other Study ID Numbers: A/6/2009-exenatide-CVS
Study First Received: January 11, 2010
Last Updated: April 26, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on June 23, 2017