Low Glycemic Diet Intervention and Community Diabetic Patients

NCT ID: NCT02575937

Last Updated: 2016-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diabetes group

During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day

Group Type EXPERIMENTAL

low glycemic diet

Intervention Type BEHAVIORAL

nutrition education-based low glycemic diet intervention

Fatty group

During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day

Group Type EXPERIMENTAL

low glycemic diet

Intervention Type BEHAVIORAL

nutrition education-based low glycemic diet intervention

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

Group Type EXPERIMENTAL

low glycemic diet

Intervention Type BEHAVIORAL

nutrition education-based low glycemic diet intervention

Interventions

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low glycemic diet

nutrition education-based low glycemic diet intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Di Li

Doctor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Xia, PhD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Min Xia, PhD

Role: CONTACT

02087332433 ext. 0086

Di Li, Postgraduate

Role: CONTACT

13544476130 ext. 0086

Other Identifiers

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ZXYZM3

Identifier Type: -

Identifier Source: org_study_id

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