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

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ClinicalTrials.gov Identifier: NCT01046721
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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 or disease Intervention/treatment
Type 2 Diabetes Drug: Exenatide Drug: Saline

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Cardiovascular Effects of Exenatide in Healthy Male Subjects
Study Start Date : September 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01046721     History of Changes
Other Study ID Numbers: A/6/2009-exenatide-CVS
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists