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| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
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Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally accepted as the cornerstone for the treatment of people with type 2 diabetes mellitus (T2DM). Consumption of low glycaemic index (GI) meals have been shown to improve glycaemic control, lipid profile and reduced systemic inflammation. However, these studies and international evidence-based nutritional recommendations are principally based on people of European ethnicity consuming fairly typical "western" diets. There are few published controlled dietary intervention studies which have attempted to determine appropriate dietary patterns for the treatment of diabetes amongst populations consuming rice-based diets.
HYPOTHESIS
This study builds on the information collected from phase 1 which involved the documentation of clinical and metabolic characteristics and dietary practices of Chinese individuals with T2DM. In addition to information from a separate study on GI testing of locally consumed carbohydrate containing foods, we have formulated a meal plan comprising of low GI carbohydrates. Participants will be randomised into the low GI (LGI) intervention arm or standard dietary intervention (SDI) arm and receive counselling and advice from a dietitian, embark on a two week protocol to test the recommended diet, be reviewed by the dietitian, and undergo a 3 to 6 day continuous glucose monitoring period before and after the LGI or SDI diet. In addition, they will undergo 2 separate single day test meals comprising of low GI and high GI foods. Participants in both groups will be given resources including detailed instructions and meal plans that are comparable between the two arms in terms of contact with research personnel, instructions and meal plans which are isocaloric and have similar macronutrient composition appropriate for their energy requirements.
Participants will be advised to continue on the meal plans and diet for a further 22 weeks. At the second month, a telephone call will be made to the participant to review compliance. At month 3 and month 6, participants will be asked to attend after an overnight fast from 10pm, for a blood sample, return a food diary/ recall, measurement of anthropometry and blood pressure. In addition, they will complete a questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard dietary intervention (SDI) arm | Active Comparator | The general principles for the SDI arm are to provide an understanding of carbohydrates, be isocaloric based on assessment from the food diary/ recall and anthropometric measures, provide a personalised even distribution of carbohydrate throughout the day, have general recommendations such as reduction of fat, sodium, sugar and an increase in fibre |
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| LGI intervention arm | Experimental | The general principles for the LGI intervention arm include the SDI principles and instructions on GI, identifying foods of different GI, switching to low GI food and having at least one low GI food per meal and suggested meals with recipes. Participants will also have the opportunity to attend sessions to learn how to cook meals with low GI. Participants will be provided with a list of low GI carbohydrates to consume during the intervention period and in addition, they will be provided with a supply of the staples for the same period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Glycemic Index (LGI) intervention arm | Other | The general principles for the LGI intervention arm include the SDI principles and instructions on GI, identifying foods of different GI, switching to low GI food and having at least one low GI food per meal and suggested meals with recipes. Participants will also have the opportunity to attend sessions to learn how to cook meals with low GI. |
| Measure | Description | Time Frame |
|---|---|---|
| Average mean glucose levels and variability | To assess the intermediate effects on glycaemia and metabolic response to a meal plan comprising of LGI compared with a SDI meal plan | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBA1C |
| 3 and 6 months |
| Glucose and Insulin Levels | To assess glycemic and metabolic response to a mixed meal |
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Inclusion Criteria:
Be willing and able to comply with study procedures and give written informed consent
Have established diagnosis of type 2 diabetes* of more than 1 year on diet treatment or oral anti-diabetic therapy
Male or female, aged 45 to 64 years inclusive
HbA1c of 7.0 - 10.0% (inclusive) within the last 3 months or at screening
Stable glycaemic control
Patients with concurrent illnesses if medically stable for 6 months prior to screening visit, based on the clinical judgement of the investigator
Be on stable therapy (no significant change to therapy in last 3 months)
No hospitalization or surgery in the past 6 months
No use of corticosteroids in the last 6 months
Not pregnant
Urea <30 mmol/L and estimated GFR >= 60ml/min
Be willing to prepare and adhere to the meal plans and consume at least two meals at home per day.
Be willing and able to undertake blood glucose monitoring, continuous glucose monitoring.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric YH Khoo, MD | Contact | 67724352 | eric_khoo@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Eric YH Khoo, MD | National University Hospital / Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | 119228 | Singapore |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard Diet Intervention | Other | The general principles for the SDI arm are to provide an understanding of carbohydrates, be isocaloric based on assessment from the food diary/ recall and anthropometric measures, provide a personalised even distribution of carbohydrate throughout the day, have general recommendations such as reduction of fat, sodium, sugar and an increase in fibre. Participants will be provided with a list of carbohydrates to take during the intervention period and will be provided a supply of carbohydrates for that period |
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| 1 week |
| D004700 | Endocrine System Diseases |