A study investigating the effects of sitagliptin on heart muscle performance in patients with heart disease and diabetes

ISRCTN ISRCTN78649100
DOI https://doi.org/10.1186/ISRCTN78649100
EudraCT/CTIS number 2008-000300-89
Secondary identifying numbers EudraCT: 2008-000300-89; DSSita-01
Submission date
15/05/2008
Registration date
11/07/2008
Last edited
18/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Dutka
Scientific

Department of Cardiovascular Medicine
Box 110
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone +44 (0)1223 331504
Email dpd24@medschl.cam.ac.uk

Study information

Study designSingle centre, interventional, open trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effects of sitagliptin (Januvia®) on myocardial performance in patients with coronary artery disease
Study objectivesIn 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(s)Ethics approval received from the Cambridge Research Ethics Committee 2 on the 1st May 2008 (ref: 08/H0304/22).
Health condition(s) or problem(s) studiedCoronary artery disease
InterventionSubjects 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sitagliptin (Januvia®)
Primary outcome measureLV 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 measures1. 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 study start date01/08/2008
Completion date31/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteriaSubjects aged 35 - 80 years with coronary disease awaiting revascularisation with normal left ventricular (LV) function with insulin resistance.
Key exclusion criteria1. Atrial fibrillation
2. Pacemakers
3. Valvular heart disease
4. Renal failure
Date of first enrolment01/08/2008
Date of final enrolment31/07/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Cardiovascular Medicine
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
Box 277
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone +44 (0)1223 274486
Email randdenquires@addenbrookes.nhs.uk
Website http://www.addenbrookes.org.uk/
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Government

Internal funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2010 Yes No