Low Glycemic Diet Intervention and Community Diabetic Patients

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

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: low glycemic diet

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

Study Locations

• China
  • Guangdong
    • 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)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes group; During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day	Behavioral: low glycemic diet; nutrition education-based low glycemic diet intervention
Experimental: Fatty group; During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day	Behavioral: low glycemic diet; nutrition education-based low glycemic diet intervention
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	Behavioral: low glycemic diet; nutrition education-based low glycemic diet intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated hemoglobin (HbA1c)	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.	Change from Baseline HbA1c at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight		Baseline and 6, 12 months
Body Mass Index (BMI)		Baseline and 6, 12 months
Fasting blood-glucose		Baseline and 6, 12 months
Total cholesterol level		Baseline and 6, 12 months
HDL level		Baseline and 6, 12 months
LDL level		Baseline and 6, 12 months
Triglycerides		Baseline and 6, 12 months
Food Frequency Questionnaire（FFQ）	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	Baseline and 6, 12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Min Xia, PhD, Sun Yat-sen University

Study record dates

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: diabetes; low glycemic diet
• Other Study ID Numbers: ZXYZM3