Clinical trial NCT01542554: Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients
Official title: Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Chinese
Glycaemic index
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2012-03-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood HbA1c
timeFrame: Baseline and week 10
Secondary outcomes:
measure: Change in pre- and 2-hour post-meal capillary blood glucose concentration
timeFrame: Baseline and week 10
measure: Change in fasting blood glucose
timeFrame: Baseline and week 10
measure: Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )
timeFrame: Baseline and week 10
measure: Change in blood ALT
timeFrame: Baseline and week 10
measure: Change in body weight
timeFrame: Baseline and week 10
measure: Change in blood pressure
timeFrame: Baseline and week 10
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Tung Wah Eastern Hospital, Hospital Authority
state: Hong Kong SAR
Study officials:
affiliation: Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
name: Ace Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/ajcn/56.6.1034.
citation: 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.
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.