Low Glycemic Diet Intervention and Community Diabetic Patients
May 3, 2016 updated by: Di Li, Sun Yat-sen University
The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients
The purpose of this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients.
Design: Randomized clinical trial.
Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）
Study Overview
Detailed Description
Low glycemic diet can help to control Blood glucose levels，this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients,and to improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and diet controlling.
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
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
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subject has a fasting blood glucose between 6.1 and 6.9mmol/L or diagnosed of type 2 diabetes
- glycosylated hemoglobin(A1C) between 6 and 11%.
- subject's age≥18 years.
Exclusion Criteria:
- subject has kidney disease (defined as creatinine>1.3 mg/dl)
- active liver or gallbladder disease
- significant heart disease
- a history of severe hypoglycemia, or use of weight loss medications.
- subject that is pregnant.
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Diabetes group
During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day
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nutrition education-based low glycemic diet intervention
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Experimental: Fatty group
During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day
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nutrition education-based low glycemic diet intervention
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Experimental: Impaired glucose tolerance group
During the trial period, the participants who are diagnosed of impaired glucose tolerance are instructed to consume low glycemic diet every day
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nutrition education-based low glycemic diet intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Glycosylated hemoglobin (HbA1c)
Time Frame: Change from Baseline HbA1c at 12 months
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Because glycosylated hemoglobin is not affected by plasma glucose fluctuation and can reflect the average blood glucose concentration over the past six to eight weeks.We take a blood sample to check participants' glycosylated hemoglobin concentration at baseline and 12 months respectively.Comparing the change of glycosylated hemoglobin levels, to investigate the effect of the our intervention method.
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Change from Baseline HbA1c at 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Weight
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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Body Mass Index (BMI)
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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Fasting blood-glucose
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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Total cholesterol level
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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HDL level
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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LDL level
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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Triglycerides
Time Frame: Baseline and 6, 12 months
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Baseline and 6, 12 months
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Food Frequency Questionnaire（FFQ）
Time Frame: Baseline and 6, 12 months
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Method of food frequency questionnaire（FFQ）can be used to monitor the individual over the specified period of time the intake frequencies of certain foods or consumption, so as to determine whether intervention affect their eating habits
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Baseline and 6, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Min Xia, PhD, Sun Yat-sen University
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
May 1, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
September 28, 2015
First Submitted That Met QC Criteria
October 13, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Estimate)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 3, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZXYZM3
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.