Low Glycemic Diet Intervention and Community Diabetic Patients

Diabetes Clinical Trial

Official title:

The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02575937
• Other study ID #: ZXYZM3
• Status: Not yet recruiting
• Phase: N/A
• First received: September 28, 2015
• Last updated: May 3, 2016
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: Min Xia, PhD
• Phone: 02087332433
• Email: xiamin[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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）

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• low glycemic diet
nutrition education-based low glycemic diet intervention

Locations

Country	Name	City	State
China	Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Weight		Baseline and 6, 12 months	No
Secondary	Body Mass Index (BMI)		Baseline and 6, 12 months	No
Secondary	Fasting blood-glucose		Baseline and 6, 12 months	No
Secondary	Total cholesterol level		Baseline and 6, 12 months	No
Secondary	HDL level		Baseline and 6, 12 months	No
Secondary	LDL level		Baseline and 6, 12 months	No
Secondary	Triglycerides		Baseline and 6, 12 months	No
Secondary	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	No