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
Scientific
Department of Cardiovascular Medicine
Box 110
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 331504 |
|---|---|
| dpd24@medschl.cam.ac.uk |
Study information
| Study design | Single centre, interventional, open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effects of sitagliptin (Januvia®) on myocardial performance in patients with coronary artery disease |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sitagliptin (Januvia®) |
| Primary outcome measure | 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 study start date | 01/08/2008 |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Subjects aged 35 - 80 years with coronary disease awaiting revascularisation with normal left ventricular (LV) function with insulin resistance. |
| Key exclusion criteria | 1. Atrial fibrillation 2. Pacemakers 3. Valvular heart disease 4. Renal failure |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 31/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiovascular Medicine
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Box 277
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 274486 |
|---|---|
| randdenquires@addenbrookes.nhs.uk | |
| Website | http://www.addenbrookes.org.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
