The American Diabetes Association (ADA), among other medical societies, is strongly recommending medical nutrition therapy (MNT) for prevention and management of type 2 diabetes. However, the ADA recognized that there is no "one size fits all" diet and thus recommends that MNT should be conducted through a consultation with registered dietitians (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an integral part of the MNT, lowers postprandial blood glucose levels. Through our experience from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying MNT within a structured dietary intervention protocol has the best impact on blood glucose values and body weight. Meanwhile, the frequent use of health coaching during dietary intervention proved to be effective in managing diabetes and inducing weight loss. However, no study compared those three intervention methods in a randomized clinical study. The aim of this study is to evaluate the effect of different models of conducting medical nutrition therapy on the glycemic control in patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Will follow the nutritional recommendations set by the American Diabetes Association in 2013.
Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.
Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula; in addition to receiving weekly coaching from a registered dietitian
Joslin Diabetes Center
Boston, Massachusetts, United States
Absolute and relative change in HbA1c
Time frame: 16 weeks
Absolute and relative change in body weight
Time frame: 16 weeks
Absolute and relative change in fasting blood glucose
Time frame: 16 weeks
Absolute and relative change in lipid profile (cholesterol, HDL, LDL, triglycerides)
Time frame: 16 weeks
Absolute and relative change in blood pressure
Time frame: 16 weeks
Absolute and relative change in High-sensitivity C - reactive protein (hsCRP)
Time frame: 16 weeks
Absolute and relative change in HOMA insulin resistance (IR) index
Time frame: 16 weeks
Absolute and relative change in c-peptide level
Time frame: 16 weeks
Absolute and relative change in microalbumin/creatinine ratio
Time frame: 16 weeks
Absolute and relative change in fat mass
Time frame: 16 weeks
Absolute and relative change in body fat percentage
Time frame: 16 weeks
Absolute and relative change in waist/hip ratio
Time frame: 16 weeks
Absolute and relative change in visceral fat content
Time frame: 16 weeks
Absolute and relative change in dietary protein
Time frame: 16 weeks
Absolute and relative change in energy intake
Time frame: 16 weeks
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