NCT02575937

Brief 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）

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

September 28, 2015

Last Update Submit

May 3, 2016

Conditions

Diabetes

Keywords

low glycemic dietdiabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Diabetes group

EXPERIMENTAL

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

Behavioral: low glycemic diet

Fatty group

EXPERIMENTAL

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

Behavioral: low glycemic diet

Impaired glucose tolerance group

EXPERIMENTAL

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

Interventions

low glycemic dietBEHAVIORAL

nutrition education-based low glycemic diet intervention

Diabetes groupFatty groupImpaired glucose tolerance group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Min Xia, PhD

    Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Min Xia, PhD

CONTACT

02087332433xiamin@mail.sysu.edu.cn

Di Li, Postgraduate

CONTACT

13544476130danyinghm@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 15, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

CN(1)