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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01585818
First received: April 25, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: Low Glycemic Index (LGI) intervention arm
Other: Standard Diet Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutrition Studies and Dietary Intervention in Individuals With Type 2 Diabetes Mellitus of Chinese, Malay and Indian Ethnicity

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Average mean glucose levels and variability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    1. To assess acceptability and compliance to the intervention meal plan
    2. To assess the intermediate effects of glycaemia

  • Glucose and Insulin Levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess glycemic and metabolic response to a mixed meal


Estimated Enrollment: 160
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585818

Contacts
Contact: Eric YH Khoo, MD 67724352 eric_khoo@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Eric YH Khoo, MD    67724352    eric_khoo@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Eric YH Khoo, MD National University Hospital / Medicine
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01585818     History of Changes
Other Study ID Numbers: SICS-10/1/2/002
Study First Received: April 25, 2012
Last Updated: January 15, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Glycemic Index
Type 2 Diabetes Mellitus
Diet
Glucose Variability
Metabolic Response
Glucose Response

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014