Diabetic Educational Eating Plan

NCT00473811 | Completed Phase 1

• 1 other identifier: 5P30DK032520-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Low-GI Dietary Education; ADA Dietary Education

Keywords

Glycemic index; carbohydrates; diabetes mellitus, type 2; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

  one year

Study Arms (2)

ADA diet

ACTIVE COMPARATOR

Patients will be encouarged to consume foods consisted with ADA dietary recommendation

Behavioral: ADA diet

Low-GI

EXPERIMENTAL

a low GI dietary education

Behavioral: Low GI

Interventions

Low GI BEHAVIORAL

low-GI education

Low-GI

ADA diet BEHAVIORAL

ADA dietary education

ADA diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• Ma Y, Olendzki BC, Hafner AR, Chiriboga DE, Culver AL, Andersen VA, Merriam PA, Pagoto SL. Low-carbohydrate and high-fat intake among adult patients with poorly controlled type 2 diabetes mellitus. Nutrition. 2006 Nov-Dec;22(11-12):1129-36. doi: 10.1016/j.nut.2006.08.006. Epub 2006 Oct 4.

  PMID: 17027229 RESULT

• Ma Y, Olendzki BC, Merriam PA, Chiriboga DE, Culver AL, Li W, Hebert JR, Ockene IS, Griffith JA, Pagoto SL. A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Nutrition. 2008 Jan;24(1):45-56. doi: 10.1016/j.nut.2007.10.008.

  PMID: 18070658 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yunsheng Ma, MD, Ph.D.

  Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: August 1, 2005
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

US (1)