Dietary Intervention in Diabetes Mellitus (DIDM)- Intermediate and Acute Effects (DIDM)
|ClinicalTrials.gov Identifier: NCT01585818|
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : April 26, 2012
Last Update Posted : January 17, 2014
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.
- The glycaemic response over 6 days as measured by CGMS will have a lower mean glucose level and postprandial increase in individuals consuming the LGI compared with the SDI meal plan.
- A LGI meal plan is acceptable and participants will adhere and comply to the diet to the same level as those receiving the SDI meal plan.
- Glycaemic and metabolic parameters as measured by integrated area under the curve (IAUC) of glucose and insulin are lower after a single meal comprising of LGI than compared with an SDI meal.
- The effect of a single meal of LGI reduces appetite and increases satiety compared with a meal of SDI.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: Low Glycemic Index (LGI) intervention arm Other: Standard Diet Intervention||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nutrition Studies and Dietary Intervention in Individuals With Type 2 Diabetes Mellitus of Chinese, Malay and Indian Ethnicity|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||August 2014|
Active Comparator: standard dietary intervention (SDI) arm
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
Other: Standard Diet Intervention
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
Other Name: SDI arm
Experimental: LGI intervention arm
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
Other: Low Glycemic Index (LGI) intervention arm
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.
Other Name: Low GI
- Average mean glucose levels and variability [ Time Frame: 2 weeks ]To assess the intermediate effects on glycaemia and metabolic response to a meal plan comprising of LGI compared with a SDI meal plan
- HBA1C [ Time Frame: 3 and 6 months ]
- To assess acceptability and compliance to the intervention meal plan
- To assess the intermediate effects of glycaemia
- Glucose and Insulin Levels [ Time Frame: 1 week ]To assess glycemic and metabolic response to a mixed meal
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585818
|Contact: Eric YH Khoo, MDemail@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Eric YH Khoo, MD 67724352 firstname.lastname@example.org|
|Principal Investigator:||Eric YH Khoo, MD||National University Hospital / Medicine|