Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:

Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01542554
• Other study ID #: HKEC-2011-080
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2012
• Last updated: August 22, 2012
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Hospital Authority, Hong Kong
• Contact: Ace Lee, MBBS
• Phone: 852-2162 6888
• Email: acelee[@]mac.com
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of low glycaemic diet on blood glucose control in Chinese type 2 diabetic patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Chinese Type 2 diabetic patient.

2. Already performing self monitoring blood glucose ( SMBG ) with pre- and post-meal readings.

3. At least 50% of 2hr post-meal capillary blood glucose values are > 9 mmol/L.

4. A1c between 7.0 to 8.0% within 2 weeks of randomization.

5. Next follow-up is scheduled to at least 12 weeks or more if currently follow-up in TWEH.

6. On stable dose of anti-diabetic drug in the preceding 10 weeks.

7. No change in anti-DM drug in the next 10 week.

8. At least 18 years old.

9. Can read and understand consent form written in Chinese.

10. Can give informed consent.

Exclusion Criteria:

1. Unexplained hypoglycaemia in last 4 weeks.

2. Using rapid onset insulin ( such as Humalog, Novorapid, Actrapid HM, Mixtard HM, Novomix and Humalog Mix ).

3. Using acarbose.

4. Anaemia.

5. Known thalassaemia.

6. Suspected or confirmed iron deficiency.

7. On warfarin.

8. Renal impairment with serum creatinine > 150 umol/L

9. Active medical illness, such as hepatitis, malignancy, infection, inflammatory arthritis, etc.

10. Unable to follow low glycaemic index diet.

11. Currently participate in other study.

12. Mentally or cognitively disable.

13. Pregnant or lactating women.

14. Hospital Authority or TWEH staff.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Low glycaemic index diet
Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
• Usual diabetic diet
Diabetic subjects will be given dietary advice without mention about glycaemic index

Locations

Country	Name	City	State
China	Tung Wah Eastern Hospital, Hospital Authority	Hong Kong SAR	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

Miller JB, Pang E, Bramall L. Rice: a high or low glycemic index food? Am J Clin Nutr. 1992 Dec;56(6):1034-6. — View Citation

Venn BS, Williams SM, Mann JI. Comparison of postprandial glycaemia in Asians and Caucasians. Diabet Med. 2010 Oct;27(10):1205-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood HbA1c		Baseline and week 10	No
Secondary	Change in pre- and 2-hour post-meal capillary blood glucose concentration		Baseline and week 10	No
Secondary	Change in fasting blood glucose		Baseline and week 10	No
Secondary	Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )		Baseline and week 10	No
Secondary	Change in blood ALT		Baseline and week 10	No
Secondary	Change in body weight		Baseline and week 10	No
Secondary	Change in blood pressure		Baseline and week 10	No