Diabetes MellitusNCT01542554
Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients
A study testing Low glycaemic index diet and Usual diabetic diet in people with Diabetes Mellitus, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Low glycaemic index diet and Usual diabetic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tung Wah Eastern Hospital, Hospital Authority
Hong Kong SAR, Hong Kong SAR
Ace Lee, MBBS, 852-21626888, acelee@mac.com
Ace Yee Lee, MBBS
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Low glycaemic index diet, Usual diabetic diet
- Keywords
- Diabetes mellitus, Chinese, Glycaemic index
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycaemic index dietOther
Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
Usual diabetic dietOther
Diabetic subjects will be given dietary advice without mention about glycaemic index
| Study group | Role | What they receive |
|---|---|---|
| Low glycaemic index diet | Experimental | Not described Receives: Other: Low glycaemic index diet |
| Usual diabetic diet | Active comparator | Not described Receives: Other: Usual diabetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood HbA1c
Measured: Baseline and week 10
Secondary outcomes (6)
Change in pre- and 2-hour post-meal capillary blood glucose concentration
Measured: Baseline and week 10
Change in fasting blood glucose
Measured: Baseline and week 10
Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )
Measured: Baseline and week 10
Change in blood ALT
Measured: Baseline and week 10
Change in body weight
Measured: Baseline and week 10
Change in blood pressure
Measured: Baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ace Lee, Hospital Authority, Hong Kong
- Investigators
- Ace Lee, MBBS, Principal investigator, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542554
- Sponsor's protocol ID
- HKEC-2011-080
- Status last verified
- Aug 2012
- First submitted
- 27 Feb 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12882846Miller 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.
PubMed 1442654Venn 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.
PubMed 20873364Jenkins 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.
PubMed 19088352
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01542554
- Acronym / sponsor ID
- HKEC-2011-080
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Chinese, Glycaemic index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of low glycaemic diet on blood glucose control in Chinese type 2 diabetic patients.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycaemic index diet | Experimental | Other: Low glycaemic index diet |
| Usual diabetic diet | Active comparator | Other: Usual diabetic diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycaemic index dietDiabetic subjects will be given dietary advice with emphasis on low glycaemic index diet | Other | Low glycaemic index diet |
| Usual diabetic dietDiabetic subjects will be given dietary advice without mention about glycaemic index | Other | Usual diabetic diet |
Primary outcome
Change in blood HbA1c
Time frame: Baseline and week 10
6 secondary outcomes
Change in pre- and 2-hour post-meal capillary blood glucose concentration
Time frame: Baseline and week 10
Change in fasting blood glucose
Time frame: Baseline and week 10
Change in lipid profile ( total cholesterol, triglycerides, LDL-C, HDL-C )
Time frame: Baseline and week 10
Change in blood ALT
Time frame: Baseline and week 10
Change in body weight
Time frame: Baseline and week 10
Change in blood pressure
Time frame: Baseline and week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Background: PubMed 12882846Brand-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.
- Background: PubMed 1442654Miller 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.
- Background: PubMed 20873364Venn 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.
- Background: PubMed 19088352Jenkins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ace Lee, MBBS principal investigator
Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hospital Authority, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycaemic index diet and Usual diabetic diet in people with Diabetes Mellitus, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ace Lee, MBBS (852-2162 6888, acelee@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood HbA1c (time frame: Baseline and week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542554, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.