Diabetic Educational Eating Plan (DEEP)

August 28, 2012 updated by: Yunsheng Ma, University of Massachusetts, Worcester

Applicability of a Low Glycemic Index Diet in Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The glycemic index (GI) is a ranking of carbohydrate containing foods according to the rate at which they raise blood glucose levels after eating. A recent meta-analysis of randomized clinical trials (RCT) suggests that choosing low GI foods has a small but clinically useful effect on medium-term glycemic control in patients with type 2 diabetes. However, in most of the reviewed RCTs, patients were fed experimental diets and therefore there is still controversy over the applicability of GI in the clinical setting for management of diabetes. In addition, there is no evidence that long-term consumption of a low GI diet will contribute to improved glycemic control in people with diabetes.

Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics. The primary outcome variable of the future large trial will be glycosylated hemoglobin levels (HbA1c), a measure reflecting average glycemic level during the preceding 2-3 months. The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups: a low GI nutrition education group (low GI group) and a standard ADA dietary education group as the control group (ADA group) (20 patients in each group).

For both groups, the intervention phase will last 6 months and consist of an initial group session, an individual session, and then four group counseling sessions. The follow-up phase will be six months and consist of two group booster sessions, one at 8-months and another at 10-months. The low GI nutritional education will be primarily targeted at a low GI diet. The focus is not on decreasing total carbohydrate intake, but rather encouraging patients to substitute low GI foods for high GI foods. The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change. Data collection points coincide with two phases of the intervention. Assessments, including demographics, anthropometric measurements, diet and physical activity recalls, and clinical data, will be conducted at baseline, and at 6 and 12 months after randomization, with blood samples collected at each interval. We will track response to recruitment, adherence, and retention. Quantitative and qualitative methods will be used to assess acceptability of the intervention.

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. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.

By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI 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. Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of type II diabetes in the medical chart
  • HbA1c level >= 7 (an indication of poor control of diabetes)
  • Currently being treated with diet, oral hypoglycemic agents and/or insulin
  • At least 21 years old
  • Telephone in home or easy access to one
  • Able to understand study protocol
  • Understands and can provide informed consent
  • Physician's approval to participate in study
  • Has a blood glucose machine or a prescription for one from their physician
  • Able to speak and read English
  • Willing to be randomized to either of the two study groups
  • Able to participate in the study for a one year length of time.

Exclusion Criteria:

  • Pregnant or planning to become pregnant during the study
  • Unable or unwilling to provide informed consent
  • Plans to move out of the area within the 12-month study period
  • Required intermittent glucocorticoid therapy within the past 3 months
  • Documented acute coronary event (MI or unstable angina) within the past 6 months
  • Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g. Crohn's disease, ulcerative colitis, end-stage renal disease)
  • Diagnosis of a psychiatric illness (i.e. dementia, psychiatric hospitalization or suicidality within the past 5 years). We will not exclude individuals with a diagnosis of depression or patients taking anti-depressants.
  • Following a low-carbohydrate high fat dietary regimen such as the Atkins diet, or currently following the South Beach Diet
  • Legally blind or has significant visual impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ADA diet
Patients will be encouarged to consume foods consisted with ADA dietary recommendation
Behavioral: ADA diet
ADA dietary education
Experimental: Low-GI
a low GI dietary education
Behavioral: Low GI
low-GI education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5P30DK032520-24 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe