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Diabetic Educational Eating Plan

NCT00473811 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-08-30

No results posted yet for this study

Summary

By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.

Primary hypotheses:

1\. Recruitment and retention rates for the low GI intervention will be satisfactory.

Secondary hypotheses:

1. Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group.
2. Participants in the low GI group will be successful in lowering the GI of their diet.
3. Participants will find the intervention acceptable.

Conditions

  • Low-GI Dietary Education
  • ADA Dietary Education

Interventions

BEHAVIORAL

Low GI

low-GI education

BEHAVIORAL

ADA diet

ADA dietary education

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Yunsheng Ma, MD, Ph.D. · Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT00473811 on ClinicalTrials.gov