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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT01046721 (opens ClinicalTrials.gov in a new tab)Other idA/6/2009-exenatide-CVS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
8 participants (actual)
Sponsor
University of Nottingham · Other
Design
Randomized · Triple masking
Countries
1 country

United Kingdom

Start
Sept 2009
Primary completion
Dec 2012
Completion
Dec 2012
First posted
12 Jan 2010 (estimated)
Last update posted
6 Mar 2018
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. N/A

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

    NCT01046721

    Sept 2009 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug
  • SalineDrug

Arms2

  • Active comparator

    Exenatide

    subcutaneous administration of Exenatide (0.02ml)

  • Placebo comparator

    0.9% Saline

    subcutaneous administration of 0.9% saline solution (0.02 ml)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. superior mesenteric (SMA) blood flow

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    Meal induced changes in superior mesenteric (SMA) blood flow - exenatide versus placebo.

Secondary outcomes(5)

  1. Blood Pressure (BP)

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    BP responses when fasted and after eating- Exenatide vs. placebo.

  2. Heart Rate (HR)

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    HR responses when fasted and after eating- Exenatide vs. placebo.

  3. Limb Blood Flow (LBF)

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    Limb Blood Flow responses when fasted and after eating- Exenatide vs. placebo.

  4. Skin Blood Flow

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    Skin Blood Flow responses when fasted and after eating- Exenatide vs. placebo.

  5. Peripheral resistance

    Time frame · 0, 30, 60, 90, 120, 150, & 180 min after meal

    Registry description

    peripheral resistance responses when fasted and after eating- Exenatide vs. placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

5 results

Investigation of the haemodynamic effects of exenatide in healthy male subjects.

Mendis et al. 2012British journal of clinical pharmacologycited by 50

PMID 22320349PMC3477345DOI 10.1111/j.1365-2125.2012.04214.xPUB-22320349

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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