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

NCT01585818 | Unknown Phase 2

• 1 other identifier: SICS-10/1/2/002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Glycemic Index; Type 2 Diabetes Mellitus; Diet; Glucose Variability; Metabolic Response; Glucose Response

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (2)

• HBA1C

  3 and 6 months

• Glucose and Insulin Levels

  1 week

Study Arms (2)

standard dietary intervention (SDI) arm

ACTIVE COMPARATOR

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

LGI intervention arm

EXPERIMENTAL

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

Interventions

Low Glycemic Index (LGI) intervention arm OTHER

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.

Also known as: Low GI

LGI intervention arm

Standard Diet Intervention OTHER

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

Also known as: SDI arm

standard dietary intervention (SDI) arm

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eric YH Khoo, MD

  National University Hospital / Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric YH Khoo, MD

CONTACT

67724352; eric_khoo@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 26, 2012
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

SG (1)