NCT01046721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

January 11, 2010

Last Update Submit

March 4, 2018

Conditions

Type 2 Diabetes

Keywords

blood pressuresuperior mesenteric artery blood flowcardiovascular effectsExenatide

Outcome Measures

Primary Outcomes (1)

  • superior mesenteric (SMA) blood flow

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

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

Secondary Outcomes (5)

  • Blood Pressure (BP)

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

  • Heart Rate (HR)

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

  • Limb Blood Flow (LBF)

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

  • Skin Blood Flow

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

  • Peripheral resistance

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

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

subcutaneous administration of Exenatide (0.02ml)

Drug: Exenatide

0.9% Saline

PLACEBO COMPARATOR

subcutaneous administration of 0.9% saline solution (0.02 ml)

Drug: Saline

Interventions

ExenatideDRUG

single dose of 5 microg Exenatide. Subcutaneous administration

Also known as: Byetta
Exenatide
SalineDRUG

subcutaneous administration of 0.9% saline solution (0.02 ml)

Also known as: 0.9% Saline solution
0.9% Saline

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • any metabolic or endocrine abnormalities,
  • clinically significant abnormalities on screening,
  • taking regular medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Human Physiology Laboratories

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (1)

  • Mendis B, Simpson E, MacDonald I, Mansell P. Investigation of the haemodynamic effects of exenatide in healthy male subjects. Br J Clin Pharmacol. 2012 Sep;74(3):437-44. doi: 10.1111/j.1365-2125.2012.04214.x.

    PMID: 22320349RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ExenatideSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Peter I Mansell, FRCP

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)