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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Low Glycemic Index (LGI) intervention arm
Standard Diet Intervention
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Glycemic Index, Type 2 Diabetes Mellitus, Diet, Glucose Variability, Metabolic Response, Glucose Response

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be willing and able to comply with study procedures and give written informed consent
  2. Have established diagnosis of type 2 diabetes* of more than 1 year on diet treatment or oral anti-diabetic therapy
  3. Male or female, aged 45 to 64 years inclusive
  4. HbA1c of 7.0 - 10.0% (inclusive) within the last 3 months or at screening
  5. Stable glycaemic control
  6. Patients with concurrent illnesses if medically stable for 6 months prior to screening visit, based on the clinical judgement of the investigator
  7. Be on stable therapy (no significant change to therapy in last 3 months)
  8. No hospitalization or surgery in the past 6 months
  9. No use of corticosteroids in the last 6 months
  10. Not pregnant
  11. Urea <30 mmol/L and estimated GFR >= 60ml/min
  12. Be willing to prepare and adhere to the meal plans and consume at least two meals at home per day.

  13. Be willing and able to undertake blood glucose monitoring, continuous glucose monitoring.

    • Subjects with Type 2 DM should have been diagnosed at least 1 years prior to the screening visit and should not have T1DM, MODY or secondary diabetes e.g. diabetes secondary to chronic pancreatitis

Exclusion Criteria:

  1. Significant medical conditions which in the Investigator's opinion would confound interpretation of the results, including but not limited to: current symptomatic cardiovascular disease, macroalbuminuria (dipstick positive proteinuria on more than 1 consecutive occasion) or renal impairment (serum creatinine above 120 umol/l), cancer, overt liver disease other than Non Alcoholic Steatohepatitis (liver enzyme levels less than 3 times upper limit of normal) or gastroparesis.
  2. Recent changes in weight of >5% over the past 6 months
  3. Significant changes in diet over the past 6 months
  4. Any use of weight reducing drugs, or on medications such as alpha-glucosidase inhibitors or insulin currently or in the past 6 months
  5. Any surgery (and bariatric surgery) in the past 6 months
  6. Any use of investigational drugs in the past 6 months
  7. Any serious illness requiring hospitalization in the past 6 months
  8. Any use of corticosteroids in the past 6 months
  9. Ongoing infection, or condition that interfered with nutrient digestion, absorption, metabolism or excretion (including gastroparesis)
  10. Allergy or intolerant to the ingredients or any of the food items in the intervention diet or to paracetamol/ acetaminophen

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard dietary intervention (SDI) arm

LGI intervention arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HBA1C
To assess acceptability and compliance to the intervention meal plan To assess the intermediate effects of glycaemia
Glucose and Insulin Levels
To assess glycemic and metabolic response to a mixed meal

Full Information

First Posted
April 25, 2012
Last Updated
January 15, 2014
Sponsor
National University Hospital, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01585818
Brief Title
Dietary Intervention in Diabetes Mellitus (DIDM)- Intermediate and Acute Effects
Acronym
DIDM
Official Title
Nutrition Studies and Dietary Intervention in Individuals With Type 2 Diabetes Mellitus of Chinese, Malay and Indian Ethnicity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Glycemic Index, Type 2 Diabetes Mellitus, Diet, Glucose Variability, Metabolic Response, Glucose Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard dietary intervention (SDI) arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
LGI intervention arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Low Glycemic Index (LGI) intervention arm
Other Intervention Name(s)
Low GI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Diet Intervention
Other Intervention Name(s)
SDI arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Average mean glucose levels and variability
Description
To assess the intermediate effects on glycaemia and metabolic response to a meal plan comprising of LGI compared with a SDI meal plan
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
HBA1C
Description
To assess acceptability and compliance to the intervention meal plan To assess the intermediate effects of glycaemia
Time Frame
3 and 6 months
Title
Glucose and Insulin Levels
Description
To assess glycemic and metabolic response to a mixed meal
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Subjects with Type 2 DM should have been diagnosed at least 1 years prior to the screening visit and should not have T1DM, MODY or secondary diabetes e.g. diabetes secondary to chronic pancreatitis Exclusion Criteria: Significant medical conditions which in the Investigator's opinion would confound interpretation of the results, including but not limited to: current symptomatic cardiovascular disease, macroalbuminuria (dipstick positive proteinuria on more than 1 consecutive occasion) or renal impairment (serum creatinine above 120 umol/l), cancer, overt liver disease other than Non Alcoholic Steatohepatitis (liver enzyme levels less than 3 times upper limit of normal) or gastroparesis. Recent changes in weight of >5% over the past 6 months Significant changes in diet over the past 6 months Any use of weight reducing drugs, or on medications such as alpha-glucosidase inhibitors or insulin currently or in the past 6 months Any surgery (and bariatric surgery) in the past 6 months Any use of investigational drugs in the past 6 months Any serious illness requiring hospitalization in the past 6 months Any use of corticosteroids in the past 6 months Ongoing infection, or condition that interfered with nutrient digestion, absorption, metabolism or excretion (including gastroparesis) Allergy or intolerant to the ingredients or any of the food items in the intervention diet or to paracetamol/ acetaminophen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric YH Khoo, MD
Phone
67724352
Email
eric_khoo@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric YH Khoo, MD
Organizational Affiliation
National University Hospital / Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric YH Khoo, MD
Phone
67724352
Email
eric_khoo@nuhs.edu.sg

12. IPD Sharing Statement

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

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