DiabetesNCT01959984
Study on the Comparison Between"Standard Noodles" and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.
A study testing 100g Standard Noodles and 75g Oral Glucose in people with Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The object of this study is to compare "100g Standard Noodles " with traditional carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the diagnosis of diabetes mellitus. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- 100g Standard Noodles and 75g Oral Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2013
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For healthy subjects:
- Between 16-70 years old.
- No weight fluctuation greater than 5% within 3 months.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .
- For subjects with impaired glucose regulation(IGR):
- Between 16-70 years old.
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- Impaired fasting glucose(IFG):6.1mM(109mg/ml)≤fasting plasma glucose(FPG)<7.0mM(126mg/ml),or impaired glucose tolerance(IGT):7.8mM（140mg/ml）≤2h plasma glucose(2hPG)<11.1mM(200mg/dl),or both.
- No weight fluctuation greater than 5% within3 months.
- Keep stable antidiabetic therapy for at least 2 months.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .
- For subjects with type 2 diabetes mellitus(T2DM):
- Between 16-70 years old.
- T2DM:diabetic symptoms plus random blood glucose(RBG)≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
- No weight fluctuation greater than 5% within 3 months.
- Keep stable antidiabetic therapy at least for 2 months.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- For subjects with type 1 diabetes mellitus(T1DM):
- Between 16-70 years old.
- T1DM:diabetic symptoms plus RBG≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
- Present at least one positive antibody of β cell including ICA,IAA,GADA,IA-2A and IA-2βA.
- No weight fluctuation greater than 5% within 3 months.
- Keep stable antidiabetic therapy for at least 2 months.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
Who cannot join
- For healthy subjects:
- Be diagnosed with diabetes or IGR in late 3 months.
- With any significant medical condition,laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
- Any medical or surgical conditions possibly affecting the experiment result.
- Participated in a clinical study involving administration of medication within 90 days.
- Donated blood or plasma or had any other significant blood loss within 2 months.
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- Any clinically significant allergic diseases.
- Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
- Smokers or users of other tobacco products in the 3 months prior to screening.
- For IGR and DM:
- History of pancreatic diseases such as pancreatic cancer or pancreatitis.
- Suffered from acute complications such as diabetic ketoacidosis and hyperosmolar coma within 3 months.
- With any significant medical condition，laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
- Malignant tumor.
- Being allergic to experiment arms.
- Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200021
About this study
The object of this study is to compare "100g Standard Noodles " with traditional carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the diagnosis of diabetes mellitus.
In this study, we will compare the different effects of "100g Standard Noodles Tolerance Test"and "75g Oral Glucose Tolerance Test"on plasma glucose, insulin, c- peptide level and the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides, in part of the subjects, the difference between "100g Steamed Bread Tolerance Test", "100g Standard Noodles Tolerance Test" and "75g Oral Glucose Tolerance Test" will be further evaluated.
- Conditions
- Diabetes
- Being tested
- 100g Standard Noodles, 75g Oral Glucose
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100g Standard NoodlesOther
Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.
75g Oral GlucoseOther
Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.
| Study group | Role | What they receive |
|---|---|---|
| 100g Standard Noodles | Experimental | 100g Standard Noodles Receives: Other: 100g Standard Noodles |
| 75g Oral Glucose | Experimental | 75g Oral Glucose Receives: Other: 75g Oral Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma glucose level.
The primary outcome measures the plasma glucose level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12 months
The insulin level.
The primary outcome measures the insulin level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12 months
The c-peptide level.
The primary outcome measures the c-peptide level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12 months
Secondary outcomes (4)
The GLP-1 level.
The outcome measures of the GLP-1 level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12months
The Glucagon level.
The outcome measures of the glucagon level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12 months
The other relevant incretin hormones levels.
The outcome measures of the relevant incretin hormones level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
Measured: 12 months
The plasma glucose, insulin, c-peptide and relevant incretin hormones level during "75g Oral Glucose Tolerance Test", "100g Standard Noodles Tolerance Test" and "100g Steamed Bread Tolerance Test".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD,PHD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959984
- Sponsor's protocol ID
- CCEMD018
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090.
PubMed 40270326
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Comparison Between"Standard Noodles" and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01959984
- Acronym / sponsor ID
- CCEMD018
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Oct 2013 (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 object of this study is to compare "100g Standard Noodles " with traditional carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the diagnosis of diabetes mellitus.
In this study, we will compare the different effects of "100g Standard Noodles Tolerance Test"and "75g Oral Glucose Tolerance Test"on plasma glucose, insulin, c- peptide level and the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides, in part of the subjects, the difference between "100g Steamed Bread Tolerance Test", "100g Standard Noodles Tolerance Test" and "75g Oral Glucose Tolerance Test" will be further evaluated.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100g Standard Noodles | Experimental | Other: 100g Standard Noodles100g Standard Noodles |
| 75g Oral Glucose | Experimental | Other: 75g Oral Glucose75g Oral Glucose |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Between 16-70 years old.
- No weight fluctuation greater than 5% within 3 months.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .
- Between 16-70 years old.
- Impaired fasting glucose(IFG):6.1mM(109mg/ml)≤fasting plasma glucose(FPG)<7.0mM(126mg/ml),or impaired glucose tolerance(IGT):7.8mM（140mg/ml）≤2h plasma glucose(2hPG)<11.1mM(200mg/dl),or both.
Key exclusion criteria (16 listed)
- Be diagnosed with diabetes or IGR in late 3 months.
- With any significant medical condition,laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
- Any medical or surgical conditions possibly affecting the experiment result.
- Participated in a clinical study involving administration of medication within 90 days.
- Donated blood or plasma or had any other significant blood loss within 2 months.
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 |
|---|---|---|
| 100g Standard NoodlesSubjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min. | Other | 100g Standard Noodles |
| 75g Oral GlucoseSubjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min. | Other | 75g Oral Glucose |
Primary outcome
The plasma glucose level.
Time frame: 12 months
The primary outcome measures the plasma glucose level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
The insulin level.
Time frame: 12 months
The primary outcome measures the insulin level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
The c-peptide level.
Time frame: 12 months
The primary outcome measures the c-peptide level at 0min,30min,60min,120min,180min during "75g Oral Glucose Tolerance Test" and "100g Standard Noodles Tolerance Test" .
4 secondary outcomes
The GLP-1 level.
Time frame: 12months
The Glucagon level.
Time frame: 12 months
The other relevant incretin hormones levels.
Time frame: 12 months
The plasma glucose, insulin, c-peptide and relevant incretin hormones level during "75g Oral Glucose Tolerance Test", "100g Standard Noodles Tolerance Test" and "100g Steamed Bread Tolerance Test".
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Derived from this study: PubMed 40270326Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090.
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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.
Guang Ning, MD,PHD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100g Standard Noodles and 75g Oral Glucose in people with Diabetes, run by Shanghai Jiao Tong University School of Medicine 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 23 inclusion and 16 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 10 Oct 2013. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The plasma glucose level. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01959984, which also lists 1 linked publication.
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 10 Oct 2013.