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

August 22, 2012 updated by: Ace Lee, Hospital Authority, Hong Kong

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ace Lee, MBBS
  • Phone Number: 852-2162 6888
  • Email: acelee@mac.com

Study Contact Backup

Study Locations

    • Hong Kong SAR
      • Hong Kong SAR, Hong Kong SAR, China
        • Recruiting
        • Tung Wah Eastern Hospital, Hospital Authority
        • Contact:
        • Principal Investigator:
          • Ace Yee Lee, MBBS
        • Sub-Investigator:
          • Marcus Wing Kai Lai, MSc, RD
        • Sub-Investigator:
          • Kelvin Chung Sau Chan, MSc,APD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ace Lee, MBBS, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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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