The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM

• Traditional MNT (Behavioral): Will follow the nutritional recommendations set by the American Diabetes Association in 2013.
• Structured MNT (Behavioral), also known as Medical Nutritional Therapy Plan: Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.
• Structured MNT plus Weekly Support (Behavioral): 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

Primary outcomes

• Absolute and relative change in HbA1c [16 weeks]

Secondary outcomes

• Absolute and relative change in body weight [16 weeks]
• Absolute and relative change in fasting blood glucose [16 weeks]
• Absolute and relative change in lipid profile (cholesterol, HDL, LDL, triglycerides) [16 weeks]
• Absolute and relative change in blood pressure [16 weeks]
• Absolute and relative change in High-sensitivity C - reactive protein (hsCRP) [16 weeks]
• Absolute and relative change in HOMA insulin resistance (IR) index [16 weeks]
• Absolute and relative change in c-peptide level [16 weeks]
• Absolute and relative change in microalbumin/creatinine ratio [16 weeks]
• Absolute and relative change in fat mass [16 weeks]
• Absolute and relative change in body fat percentage [16 weeks]
• Absolute and relative change in waist/hip ratio [16 weeks]
• Absolute and relative change in visceral fat content [16 weeks]
• Absolute and relative change in dietary protein [16 weeks]
• Absolute and relative change in energy intake [16 weeks]

Sex: All, ages: 30 Years to 80 Years

Inclusion Criteria:

1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
2. Subject states that he/she had type 2 diabetes, as evidenced by use of anti-hyperglycemic medication or managed on lifestyle intervention only with A1C >7%
3. Subject is between 30 and 80 years of age.
4. Subject on stable dose of antihyperglycemic medications for the past 3 months or lifestyle intervention
5. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
6. If a female is of childbearing potential, she is practicing one of the following methods of birth control (and continued through the duration of the study):

   * Condoms, sponge, diaphragm or intrauterine device;
   * Oral or parenteral contraceptives for 3 months prior to screening visit;
   * Vasectomized partner;
   * Total abstinence from sexual intercourse.
7. Subject's BMI is > 25 kg/m2.
8. Subject has A1C between 7-10%
9. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory.

Exclusion Criteria:

1. Subjects using exogenous insulin since insulin titration may impact the primary endpoint.
2. Subject states that he/she had a history of diabetic ketoacidosis.
3. Subject is pregnant or lactating.
4. Subject uses corticosteroid treatment with the exception of inhaled or topical steroids in the last 3 months; or antibiotics within the last 3 weeks prior to the screening visit.
5. Subject states that he/she had an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
6. Subject states that he/she has had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.
7. Subject states that he/she has had end stage organ failure (such as end stage renal disease) or had status post organ transplant.
8. Subject states that he/she has had a history of renal disease (Creatinine >1.5mg/dL or GFR <60 mL/min/1.73 m2).
9. Subject states that he/she has had current hepatic disease.
10. Subject has history of gastroparesis.
11. Subject states that he/she has had a chronic, contagious, infectious disease
12. Subject states that he/she has had clotting or bleeding disorders.
13. Subject is known to be allergic or intolerant to any ingredient found in the study products.
14. Subject is known to have a history of special nutritional need requiring special diet.
15. Subject is currently participating in any weight loss program.
16. Subject has used meal replacements during the 3 months prior to the start of the study.
17. Subject has history of bariatric surgery.

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• Results publication: Mottalib A, Salsberg V, Mohd-Yusof BN, Mohamed W, Carolan P, Pober DM, Mitri J, Hamdy O. Effects of nutrition therapy on HbA1c and cardiovascular disease risk factors in overweight and obese patients with type 2 diabetes. Nutr J. 2018 Apr 7;17(1):42. doi: 10.1186/s12937-018-0351-0. PMID 29626933

• Osama Hamdy, MD, PhD, Principal investigator, Joslin Diabetes Center