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

NCT02520050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-03-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Traditional MNT

Will follow the nutritional recommendations set by the American Diabetes Association in 2013.

BEHAVIORAL

Structured MNT

Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.

BEHAVIORAL

Structured MNT plus Weekly Support

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

Sponsors & Collaborators

  • Metagenics, Inc.

    collaborator INDUSTRY

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Osama Hamdy, MD, PhD · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520050 on ClinicalTrials.gov