Study on the Comparison BetweenStandard Noodles and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.

Study Overview
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Brief Summary
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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 Testand 75g Oral Glucose Tolerance Teston 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.

Official Title
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Study on the Comparison BetweenStandard Noodles and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.

Conditions
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Diabetes

Intervention / Treatment
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* Other: 100g Standard Noodles
* Other: 75g Oral Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100g Standard Noodles<br>100g Standard Noodles | Other: 100g Standard Noodles<br>* Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.<br>|
| Experimental: 75g Oral Glucose<br>75g Oral Glucose | Other: 75g Oral Glucose<br>* Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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 . | 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 . | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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 . | 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 . | 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. |  | 12 months |