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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01959984
• Other study ID #: CCEMD018
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2013
• Last updated: October 9, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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 ß cell including ICA,IAA,GADA,IA-2A and IA-2ßA.

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• 100g Standard Noodles
Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.
• 75g Oral Glucose
Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Document the frequency and extent of side-effects.	12 months	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No