Study on the Comparison Between"Standard Noodles" and Traditional Carbohydrates in the Diagnosis of Diabetes Mellitus.

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 Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Other: 100g Standard Noodles; Other: 75g Oral Glucose

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200021
      • Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion Criteria:

For healthy subjects:

1. Between 16-70 years old.
2. No weight fluctuation greater than 5% within 3 months.
3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .

For subjects with impaired glucose regulation(IGR):

1. Between 16-70 years old.
2. 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.
3. No weight fluctuation greater than 5% within3 months.
4. Keep stable antidiabetic therapy for at least 2 months.
5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures .

For subjects with type 2 diabetes mellitus(T2DM):

1. Between 16-70 years old.
2. T2DM:diabetic symptoms plus random blood glucose(RBG)≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
3. No weight fluctuation greater than 5% within 3 months.
4. Keep stable antidiabetic therapy at least for 2 months.
5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.

For subjects with type 1 diabetes mellitus(T1DM):

1. Between 16-70 years old.
2. T1DM:diabetic symptoms plus RBG≥11.1mM,or FPG ≥7.0mM(126mg/dl),or 2hPG ≥11.1mM(200mg/dl).
3. Present at least one positive antibody of β cell including ICA,IAA,GADA,IA-2A and IA-2βA.
4. No weight fluctuation greater than 5% within 3 months.
5. Keep stable antidiabetic therapy for at least 2 months.
6. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.

Exclusion Criteria:

For healthy subjects:

1. Be diagnosed with diabetes or IGR in late 3 months.
2. With any significant medical condition,laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
3. Any medical or surgical conditions possibly affecting the experiment result.
4. Participated in a clinical study involving administration of medication within 90 days.
5. Donated blood or plasma or had any other significant blood loss within 2 months.
6. Any clinically significant allergic diseases.
7. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
8. Smokers or users of other tobacco products in the 3 months prior to screening.

For IGR and DM:

1. History of pancreatic diseases such as pancreatic cancer or pancreatitis.
2. Suffered from acute complications such as diabetic ketoacidosis and hyperosmolar coma within 3 months.
3. With any significant medical condition，laboratory abnormality,or psychiatric disorders that will prevent the subject from participating in the study.
4. Malignant tumor.
5. Being allergic to experiment arms.
6. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Document the frequency and extent of side-effects.	12 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 29, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CCEMD018