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

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ClinicalTrials.gov Identifier: NCT01542554
Recruitment Status : Unknown
Verified August 2012 by Ace Lee, Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : March 2, 2012
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Mellitus 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients: Randomized Controlled Trial
Study Start Date : March 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Change in blood HbA1c [ Time Frame: Baseline and week 10 ]

Secondary Outcome Measures :
  1. Change in pre- and 2-hour post-meal capillary blood glucose concentration [ Time Frame: Baseline and week 10 ]
  2. Change in fasting blood glucose [ Time Frame: Baseline and week 10 ]
  3. Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C ) [ Time Frame: Baseline and week 10 ]
  4. Change in blood ALT [ Time Frame: Baseline and week 10 ]
  5. Change in body weight [ Time Frame: Baseline and week 10 ]
  6. Change in blood pressure [ Time Frame: Baseline and week 10 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542554

Contact: Ace Lee, MBBS 852-2162 6888 acelee@mac.com
Contact: Marcus Lai, MSc, RD 852-2162 6888 lwk053@ha.org.hk

China, Hong Kong SAR
Tung Wah Eastern Hospital, Hospital Authority Recruiting
Hong Kong SAR, Hong Kong SAR, China
Contact: Ace Lee, MBBS    852-21626888    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         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Principal Investigator: Ace Lee, MBBS Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong