Dietary Intervention in Diabetes Mellitus (DIDM)- Intermediate and Acute Effects — DIDM  

Type 2 Diabetes Mellitus Clinical Trial

Official title: Nutrition Studies and Dietary Intervention in Individuals With Type 2 Diabetes Mellitus of Chinese, Malay and Indian Ethnicity

Status Recruiting

Clinical Trial Summary

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

1. 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.

2. 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.

3. 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.

4. The effect of a single meal of LGI reduces appetite and increases satiety compared with a meal of SDI.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT01585818
• Study type: Interventional
• Source: National University Hospital, Singapore
• Contact: Eric YH Khoo, MD
• Phone: 67724352
• Email: eric_khoo@nuhs.edu.sg
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2011
• Completion date: August 2014