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

NCT01585818 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-01-17

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV
  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Eric YH Khoo, MD · National University Hospital / Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585818 on ClinicalTrials.gov