- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542554
Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients
Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Glycaemic index (GI) is the measurement of post-meal blood glucose rise cause by ingestion of carbohydrate. For the same amount of carbohydrate, food with lower GI value cause a lower post- meal rise in blood glucose concentration in both normal and diabetic patients. Meta-analysis of randomized controlled trial has showed that low GI diet can achieve an additional reduction of A1c by 0.4% when compare with usual diabetic diet. Furthermore, various diabetes associations have already endorsed the use of low GI diet in the management of diabetes.
Hong Kong Chinese obtain most of their carbohydrate intake through consumption of rice or rice related foods, which are considered as having high GI value. In addition, it has been demonstrated that Asian have higher post-prandial rise in blood glucose than Caucasian after consuming the same amount of carbohydrate. When the above two factors add together, we expect our local type 2 diabetic patients are suffering from significant post-prandial hyperglycaemia, which in turn translate into elevated 24-hour hyperglycaemia and A1c.
However, nearly all studies about glycaemic index and diabetes are conducted in Caucasian. It is unclear about the benefit in Chinese patients with type 2 diabetes who are currently having diet with high GI value.
We therefore hypothesized that low GI diet may improve blood glucose control in Chinese type 2 diabetic patients. To test this hypothesis, we plan to conduct this randomized controlled trial about low GI diet in Chinese diabetic patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ace Lee, MBBS
- Phone Number: 852-2162 6888
- Email: acelee@mac.com
Study Contact Backup
- Name: Marcus Lai, MSc, RD
- Phone Number: 852-2162 6888
- Email: lwk053@ha.org.hk
Study Locations
-
-
Hong Kong SAR
-
Hong Kong SAR, Hong Kong SAR, China
- Recruiting
- Tung Wah Eastern Hospital, Hospital Authority
-
Contact:
- Ace Lee, MBBS
- Phone Number: 852-21626888
- Email: acelee@mac.com
-
Principal Investigator:
- Ace Yee Lee, MBBS
-
Sub-Investigator:
- Marcus Wing Kai Lai, MSc, RD
-
Sub-Investigator:
- Kelvin Chung Sau Chan, MSc,APD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chinese Type 2 diabetic patient.
- Already performing self monitoring blood glucose ( SMBG ) with pre- and post-meal readings.
- At least 50% of 2hr post-meal capillary blood glucose values are > 9 mmol/L.
- A1c between 7.0 to 8.0% within 2 weeks of randomization.
- Next follow-up is scheduled to at least 12 weeks or more if currently follow-up in TWEH.
- On stable dose of anti-diabetic drug in the preceding 10 weeks.
- No change in anti-DM drug in the next 10 week.
- At least 18 years old.
- Can read and understand consent form written in Chinese.
- Can give informed consent.
Exclusion Criteria:
- Unexplained hypoglycaemia in last 4 weeks.
- Using rapid onset insulin ( such as Humalog, Novorapid, Actrapid HM, Mixtard HM, Novomix and Humalog Mix ).
- Using acarbose.
- Anaemia.
- Known thalassaemia.
- Suspected or confirmed iron deficiency.
- On warfarin.
- Renal impairment with serum creatinine > 150 umol/L
- Active medical illness, such as hepatitis, malignancy, infection, inflammatory arthritis, etc.
- Unable to follow low glycaemic index diet.
- Currently participate in other study.
- Mentally or cognitively disable.
- Pregnant or lactating women.
- Hospital Authority or TWEH staff.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low glycaemic index diet
|
Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
|
Active Comparator: Usual diabetic diet
|
Diabetic subjects will be given dietary advice without mention about glycaemic index
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood HbA1c
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pre- and 2-hour post-meal capillary blood glucose concentration
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Change in fasting blood glucose
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Change in blood ALT
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Change in body weight
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Change in blood pressure
Time Frame: Baseline and week 10
|
Baseline and week 10
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ace Lee, MBBS, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
Publications and helpful links
General Publications
- Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
- Brand-Miller J, Hayne S, Petocz P, Colagiuri S. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003 Aug;26(8):2261-7. doi: 10.2337/diacare.26.8.2261.
- Miller JB, Pang E, Bramall L. Rice: a high or low glycemic index food? Am J Clin Nutr. 1992 Dec;56(6):1034-6. doi: 10.1093/ajcn/56.6.1034.
- Venn BS, Williams SM, Mann JI. Comparison of postprandial glycaemia in Asians and Caucasians. Diabet Med. 2010 Oct;27(10):1205-8. doi: 10.1111/j.1464-5491.2010.03069.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKEC-2011-080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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