Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2005-08-31
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ADA diet
Patients will be encouarged to consume foods consisted with ADA dietary recommendation
ADA diet
ADA dietary education
Low-GI
a low GI dietary education
Low GI
low-GI education
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low GI
low-GI education
ADA diet
ADA dietary education
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Massachusetts, Worcester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yunsheng Ma
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yunsheng Ma, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.