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
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
-
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.