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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
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

February 27, 2012
August 22, 2012
March 2012
December 2012   (final data collection date for primary outcome measure)
Change in blood HbA1c [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01542554 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • 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
  • Other: Usual diabetic diet
    Diabetic subjects will be given dietary advice without mention about glycaemic index
    Other Name: Usual diabetic diet
  • Experimental: Low glycaemic index diet
    Intervention: Other: Low glycaemic index diet
  • Active Comparator: Usual diabetic diet
    Intervention: Other: Usual diabetic diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Ace Lee, MBBS 852-2162 6888 acelee@mac.com
Contact: Marcus Lai, MSc, RD 852-2162 6888 lwk053@ha.org.hk
China
 
NCT01542554
HKEC-2011-080
No
Ace Lee, Hospital Authority, Hong Kong
Hospital Authority, Hong Kong
Not Provided
Principal Investigator: Ace Lee, MBBS Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
Hospital Authority, Hong Kong
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP