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 |
| Clinical Trials Information System (CTIS) | 2008-000300-89 |
| Protocol serial number | EudraCT: 2008-000300-89; DSSita-01 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Internal funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single centre, interventional, open trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sitagliptin (Januvia®) |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Tissue Doppler |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Cardiovascular Medicine
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
