The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM
The Effect of Three Different Models of Medical Nutrition Therapy (MNT) on Diabetes Control in Overweight and Obese Patients With Type 2 Diabetes: A Randomized Comparative Study. (Nutrition Path Study)
1 other identifier
interventional
108
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Apr 2015
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMarch 4, 2019
February 1, 2019
3.3 years
August 4, 2015
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute and relative change in HbA1c
16 weeks
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (3)
Traditional MNT
ACTIVE COMPARATORWill be instructed to follow a MNT plan as recommended by the ADA through consultation with a RD.
Structured MNT
ACTIVE COMPARATORWill be instructed to follow a MNT plan as applied in the Why WAIT™ program, which includes structured dietary plan, dietary modification and use of diabetes-specific meal replacement (Ultra Glucose Control®; Metagenics Inc.) three times per day.
Structured MNT plus Weekly Support
ACTIVE COMPARATORWill be instructed to follow a MNT plan as applied in the Why WAIT™ program, which includes structured dietary plan, dietary modification and use of diabetes-specific meal-replacement (Ultra Glucose Control®; Metagenics Inc.) three times per day plus weekly coaching.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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%
- Subject is between 30 and 80 years of age.
- Subject on stable dose of antihyperglycemic medications for the past 3 months or lifestyle intervention
- 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).
- 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.
- Subject's BMI is \> 25 kg/m2.
- Subject has A1C between 7-10%
- 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.
You may not qualify if:
- Subjects using exogenous insulin since insulin titration may impact the primary endpoint.
- Subject states that he/she had a history of diabetic ketoacidosis.
- Subject is pregnant or lactating.
- 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.
- 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).
- 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.
- Subject states that he/she has had end stage organ failure (such as end stage renal disease) or had status post organ transplant.
- Subject states that he/she has had a history of renal disease (Creatinine \>1.5mg/dL or GFR \<60 mL/min/1.73 m2).
- Subject states that he/she has had current hepatic disease.
- Subject has history of gastroparesis.
- Subject states that he/she has had a chronic, contagious, infectious disease
- Subject states that he/she has had clotting or bleeding disorders.
- Subject is known to be allergic or intolerant to any ingredient found in the study products.
- Subject is known to have a history of special nutritional need requiring special diet.
- Subject is currently participating in any weight loss program.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joslin Diabetes Centerlead
- Metagenics, Inc.collaborator
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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: 29626933DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama Hamdy, MD, PhD
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 11, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
March 4, 2019
Record last verified: 2019-02