DiabetesNCT02575937
Low Glycemic Diet Intervention and Community Diabetic Patients
A study testing low glycemic diet in people with Diabetes, run by Sun Yat-sen University at 1 site in China.
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） Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- low glycemic diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: 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）
Read the 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.
- Conditions
- Diabetes
- Being tested
- low glycemic diet
- Keywords
- low glycemic diet, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low glycemic dietBehavioural
nutrition education-based low glycemic diet intervention
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Experimental | During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day Receives: 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 Receives: 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 Receives: Behavioral: low glycemic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline HbA1c at 12 months
Secondary outcomes (8)
Weight
Measured: Baseline and 6, 12 months
Body Mass Index (BMI)
Measured: Baseline and 6, 12 months
Fasting blood-glucose
Measured: Baseline and 6, 12 months
Total cholesterol level
Measured: Baseline and 6, 12 months
HDL level
Measured: Baseline and 6, 12 months
LDL level
Measured: Baseline and 6, 12 months
Triglycerides
Measured: 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
Measured: Baseline and 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Li, Sun Yat-sen University
- Investigators
- Min Xia, PhD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575937
- Sponsor's protocol ID
- ZXYZM3
- Status last verified
- May 2016
- First submitted
- 28 Sep 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients
- ClinicalTrials.gov ID
- NCT02575937
- Acronym / sponsor ID
- ZXYZM3
- Conditions
- Diabetes
- Keywords
- low glycemic diet, diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes group | Experimental | Behavioral: low glycemic dietDuring the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day |
| Fatty group | Experimental | Behavioral: low glycemic dietDuring the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day |
| Impaired glucose tolerance group | Experimental | Behavioral: low glycemic dietDuring the trial period, the participants who are diagnosed of impaired glucose tolerance are instructed to consume low glycemic diet every day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low glycemic dietnutrition education-based low glycemic diet intervention | Behavioural | Diabetes group, Fatty group, Impaired glucose tolerance group |
Primary outcome
Change in Glycosylated hemoglobin (HbA1c)
Time frame: Change from Baseline HbA1c at 12 months
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.
8 secondary outcomes
Weight
Time frame: Baseline and 6, 12 months
Body Mass Index (BMI)
Time frame: Baseline and 6, 12 months
Fasting blood-glucose
Time frame: Baseline and 6, 12 months
Total cholesterol level
Time frame: Baseline and 6, 12 months
HDL level
Time frame: Baseline and 6, 12 months
LDL level
Time frame: Baseline and 6, 12 months
Triglycerides
Time frame: Baseline and 6, 12 months
Food Frequency Questionnaire（FFQ）
Time frame: Baseline and 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Xia, PhD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low glycemic diet in people with Diabetes, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Xia, PhD (02087332433 ext. 0086, xiamin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated hemoglobin (HbA1c) (time frame: Change from Baseline HbA1c at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.