A study of supplementation with Curcumin to Diabetics
| ISRCTN | ISRCTN49723587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49723587 |
| Secondary identifying numbers | 003 |
- Submission date
- 27/04/2010
- Registration date
- 14/06/2010
- Last edited
- 21/09/2010
- 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
Prof Sun Changhao
Scientific
Scientific
157 Baojian Road
Nangang District
Harbin
150081
China
| Phone | +86 (0)451 87502801 |
|---|---|
| sun2002changhao@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Supplementation with curcumin versus placebo treatment to lower blood glucose in diabetics: a randomised controlled trial |
| Study acronym | CD |
| Study objectives | The function of curcumin in lowering blood glucose in diabetic patients. |
| Ethics approval(s) | Medical Ethics Committee of Public Health College, Harbin Medical University, approved on the 25th June 2009 (ref: 003) |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | We determine glucose and insulin with related blood indicators in a hospital. The drug name is Curcumin Qingtang tablet. The dosage given is 2.0 g/60 kg BW/d, equivalent Curcumin 300 mg/kg, take this drug orally for a month. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Curcumin |
| Primary outcome measure | Amended as of 21/09/2010: 1. Lipids (triglycerides [TG], total cholestrol [TC], low-density liporotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C]) 2. Free fatty acids (FFAs) 3. Lipoprotein lipase (LPL) 4. Adipocyte fatty acid-binding protein (AFABP) 5. Liver ultrasonography 6. HbA1c 7. Apolipoproteins (ApoA1/ApoB) 8. Triacylglycerol 9. Cholesterol 10. 2-hour post-prandial glucose 11. Homeostasis model assessment - insulin resistance (HOMA-IR) Initial information at time of registration: 1. Glucose 2. Insulin |
| Secondary outcome measures | Amended as of 21/09/2010: 1. Age 2. Body mass index (BMI) 3. Diabetes duration 4. Cigarette use 5. Physical activity level 6. Food Frequency Questionnaire (FFQ) Initial information at time of registration: 1. Red blood cell 2. White blood cell 3. Haemoglobin 4. Total protein 5. Albumin 6. Urea nitrogen 7. Creatinine 8. Alanine transaminase 9. Aspartate transaminase 10. Platelet count 11. Height 12. Weight 13. Waist circumference 14. Hip circumference 15. Blood pressure |
| Overall study start date | 01/05/2009 |
| Completion date | 30/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Type 2 diabetes mellitus; the condition of patients are stable 2. Fasting blood glucose greater than or equal to 7.8 mmol/L or postprandial blood glucose greater than or equal to 11.1 mmol/L 3. Aged 18 - 65 years, both male and female |
| Key exclusion criteria | 1. Type I diabetes 2. Pregnant or lactating women, or allergic to the tested samples 3. Have history of liver, kidney, hypertension, mental illness, taking other hypoglycaemics 4. People are uncooperative 5. Have diabetic ketosis, acidosis and infection in recent 3 months 6. Taking correlated medications which could potentially influence the purpose of this study 7. Failing to take drugs or the information is incomplete |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 30/07/2009 |
Locations
Countries of recruitment
- China
Study participating centre
157 Baojian Road
Harbin
150081
China
150081
China
Sponsor information
Public Health College - Harbin Medical University (China)
University/education
University/education
c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China
| Phone | +86 (0)451 87502801 |
|---|---|
| sun2002changhao@yahoo.com | |
| Website | http://yxzy.hrbmu.edu.cn/gongwei/english/home.asp?id=400 |
"ROR" |
https://ror.org/05jscf583 |
Funders
Funder type
Research organisation
Amended as of 21/09/2010:
No information available
National Natural Science Foundation of China (NSFC) (China) and Canadian Institutes of Health Research (CIHR) (Canada) - China-Canada Joint Health Research Initiative (ref: 30810107)
No information available
Initial information at time of registration:
No information available
Development of Health Foods (China)
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 |
