NCT01542554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

February 27, 2012

Last Update Submit

August 22, 2012

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitusChineseGlycaemic index

Outcome Measures

Primary Outcomes (1)

  • Change in blood HbA1c

    Baseline and week 10

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Low glycaemic index diet

EXPERIMENTAL
Other: Low glycaemic index diet

Usual diabetic diet

ACTIVE COMPARATOR
Other: Usual diabetic diet

Interventions

Low glycaemic index dietOTHER

Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet

Low glycaemic index diet
Usual diabetic dietOTHER

Diabetic subjects will be given dietary advice without mention about glycaemic index

Usual diabetic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese Type 2 diabetic patient.
  • Already performing self monitoring blood glucose ( SMBG ) with pre- and post-meal readings.
  • At least 50% of 2hr post-meal capillary blood glucose values are \> 9 mmol/L.
  • A1c between 7.0 to 8.0% within 2 weeks of randomization.
  • Next follow-up is scheduled to at least 12 weeks or more if currently follow-up in TWEH.
  • On stable dose of anti-diabetic drug in the preceding 10 weeks.
  • No change in anti-DM drug in the next 10 week.
  • At least 18 years old.
  • Can read and understand consent form written in Chinese.
  • Can give informed consent.

You may not qualify if:

  • Unexplained hypoglycaemia in last 4 weeks.
  • Using rapid onset insulin ( such as Humalog, Novorapid, Actrapid HM, Mixtard HM, Novomix and Humalog Mix ).
  • Using acarbose.
  • Anaemia.
  • Known thalassaemia.
  • Suspected or confirmed iron deficiency.
  • On warfarin.
  • Renal impairment with serum creatinine \> 150 umol/L
  • Active medical illness, such as hepatitis, malignancy, infection, inflammatory arthritis, etc.
  • Unable to follow low glycaemic index diet.
  • Currently participate in other study.
  • Mentally or cognitively disable.
  • Pregnant or lactating women.
  • Hospital Authority or TWEH staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah Eastern Hospital, Hospital Authority

Hong Kong SAR, Hong Kong SAR, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 12882846BACKGROUND

  • 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.

    PMID: 1442654BACKGROUND

  • 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.

    PMID: 20873364BACKGROUND

  • 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.

    PMID: 19088352BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ace Lee, MBBS

    Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ace Lee, MBBS

CONTACT

852-2162 6888acelee@mac.com

Marcus Lai, MSc, RD

CONTACT

852-2162 6888lwk053@ha.org.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

CN(1)