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The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM | Clinical Trials | Clareo Health

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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)

NCT02520050•Joslin Diabetes Center

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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.
+8 more criteria

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

July 1, 2018

Completion Date

July 1, 2018

Last Updated

March 4, 2019

Enrollment

108

ACTUAL participants

Conditions

Type 2 DiabetesObesity

Interventions

Traditional MNT

BEHAVIORAL

Structured MNT

BEHAVIORAL

Structured MNT plus Weekly Support

BEHAVIORAL

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MenopausePerimenopause+2 more

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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