Low Glycemic Diet Intervention and Community Diabetic Patients

Sun Yat-sen University

Status: Unknown

Conditions: Diabetes

Treatments: Behavioral: low glycemic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02575937

ZXYZM3

Details and patient eligibility

About

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）

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Diabetes group

Experimental group

Description:

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

Treatment:

Behavioral: low glycemic diet

Fatty group

Experimental group

Description:

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

Treatment:

Behavioral: low glycemic diet

Impaired glucose tolerance group

Experimental group

Description:

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

Treatment:

Behavioral: low glycemic diet