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

NCT ID: NCT01959984

Last Updated: 2013-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

100g Standard Noodles

100g Standard Noodles

Group Type: EXPERIMENTAL

100g Standard Noodles

Intervention Type: OTHER

Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.

75g Oral Glucose

75g Oral Glucose

Group Type: EXPERIMENTAL

75g Oral Glucose

Intervention Type: OTHER

Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.

Interventions

100g Standard Noodles

Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.

Intervention Type: OTHER

75g Oral Glucose

Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.

Intervention Type: OTHER

Eligibility 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.)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guang Ning

the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Ning, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40270326 (View on PubMed)

Other Identifiers

CCEMD018

Identifier Type: -

Identifier Source: org_study_id