Diabetic Educational Eating Plan

Completed · Phase 1/Phase 2

Conditions studied: Low-GI Dietary Education, ADA Dietary Education

In brief

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.

Key facts

Study ID

NCT00473811

Run by

University of Massachusetts, Worcester

People needed

40

Starts

2005-08-01

Expected to finish

2012-08-01

Last updated by the study team

2012-08-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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