Condition category
Circulatory System
Date applied
15/05/2008
Date assigned
11/07/2008
Last edited
18/01/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Dutka

ORCID ID

Contact details

Department of Cardiovascular Medicine
Box 110
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 331504
dpd24@medschl.cam.ac.uk

Additional identifiers

EudraCT number

2008-000300-89

ClinicalTrials.gov number

Protocol/serial number

EudraCT: 2008-000300-89; DSSita-01

Study information

Scientific title

The effects of sitagliptin (Januvia®) on myocardial performance in patients with coronary artery disease

Acronym

Study hypothesis

In patients with insulin resistance (independent of type two diabetes mellitus) and coronary disease, sitagliptin will promote myocardial glucose utilisation and protect the heart against post-ischaemic left ventricular dysfunction and improve the myocardial response to dobutamine stress.

Ethics approval

Ethics approval received from the Cambridge Research Ethics Committee 2 on the 1st May 2008 (ref: 08/H0304/22).

Study design

Single centre, interventional, open trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

Subjects undergo two dobutamine stress echoes (DSE) (which last about half an hour) one week apart. Before the control DSE they are given a 75 g solution of glucose to drink. Before the other DSE they are given a single, oral dose of 100 mg of sitagliptin (Januvia®) and a 75 g oral glucose solution. A number of different DSE measurements are then compared between the two scans.

Intervention type

Drug

Phase

Not Specified

Drug names

Sitagliptin (Januvia®)

Primary outcome measures

LV performance during dobutamine stress echocardiography (wall motion scoring and ejection fraction [EF]), taken at baseline, peak dobutamine stress and in recovery for each DSE.

Secondary outcome measures

1. Tissue Doppler
2. Strain imaging
3. Strain rate

These outcome measures are taken at baseline, peak dobutamine stress and in recovery for each DSE.

Overall trial start date

01/08/2008

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects aged 35 - 80 years with coronary disease awaiting revascularisation with normal left ventricular (LV) function with insulin resistance.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Atrial fibrillation
2. Pacemakers
3. Valvular heart disease
4. Renal failure

Recruitment start date

01/08/2008

Recruitment end date

31/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiovascular Medicine
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 274486
randdenquires@addenbrookes.nhs.uk

Sponsor type

Government

Website

http://www.addenbrookes.org.uk/

Funders

Funder type

Government

Funder name

Internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20075143

Publication citations

  1. Results

    Read PA, Khan FZ, Heck PM, Hoole SP, Dutka DP, DPP-4 inhibition by sitagliptin improves the myocardial response to dobutamine stress and mitigates stunning in a pilot study of patients with coronary artery disease., Circ Cardiovasc Imaging, 2010, 3, 2, 195-201, doi: 10.1161/CIRCIMAGING.109.899377.

Additional files

Editorial Notes