Metabolic effects of Diabecinn (oral cinnamon extract) in diabetes type 2, a placebo-controlled randomized clinical trial
| ISRCTN | ISRCTN36704940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36704940 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | OTC Pharma |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 28/04/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.H. DeVries
Scientific
Scientific
Academic Medical Center
Department of Internal Medicine, F4-222
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| j.h.devries@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Diabecinn trial |
| Study objectives | The main objective of this randomized, placebo-controlled trial is to determine the effects of cinnamon extract on HbA1c and lipid profiles in type 2 diabetic patients. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Diabetes Mellitus type 2 (DM type II) |
| Intervention | Diabecinn three times a day (tid) or placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Diabecinn |
| Primary outcome measure(s) | HbA1c. |
| Key secondary outcome measure(s) | 1. Lipid profile 2. 6 point glucose profile 3. Hypoglycemia 4. Body weight 5. Free fatty acids 6. C-reactive protein (CRP) |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Type 2 diabetes patients 2. Age 35-70 years inclusive 3. HbA1c between 7 and 12% inclusive |
| Key exclusion criteria | 1. Pregnancy 2. Breast-feeding |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
