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

This study is currently recruiting participants.
Verified August 2012 by Hospital Authority, Hong Kong
Sponsor:
Information provided by (Responsible Party):
Ace Lee, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT01542554
First received: February 27, 2012
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus
 Other: Low glycaemic index diet
Other: Usual diabetic diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Change in blood HbA1c [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pre- and 2-hour post-meal capillary blood glucose concentration [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
  • Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C ) [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
  • Change in blood ALT [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low glycaemic index diet Other: Low glycaemic index diet
Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
Other Name: 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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542554

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

Locations
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
Investigators
Principal Investigator: Ace Lee, MBBS Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
  More Information

Publications:

Responsible Party: Ace Lee, Doctor, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT01542554     History of Changes
Other Study ID Numbers: HKEC-2011-080
Study First Received: February 27, 2012
Last Updated: August 22, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Diabetes mellitus
Chinese
Glycaemic index

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013