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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Low glycaemic index diet; Other: Usual diabetic diet

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: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low glycaemic index diet	Other: Low glycaemic index diet; Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
Active Comparator: Usual diabetic diet	Other: 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	Baseline and week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in pre- and 2-hour post-meal capillary blood glucose concentration	Baseline and week 10
Change in fasting blood glucose	Baseline and week 10
Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )	Baseline and week 10
Change in blood ALT	Baseline and week 10
Change in body weight	Baseline and week 10
Change in blood pressure	Baseline and week 10

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• 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: March 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Chinese; Diabetes mellitus; Glycaemic index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HKEC-2011-080