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

NCT01959984 | Unknown DMC

• 1 other identifier: CCEMD018
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The GLP-1 level.

  12months

• The Glucagon level.

  12 months

• The other relevant incretin hormones levels.

  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 Outcomes (1)

• Safety

  12 months

Study Arms (2)

100g Standard Noodles

EXPERIMENTAL

100g Standard Noodles

Other: 100g Standard Noodles

75g Oral Glucose

EXPERIMENTAL

75g Oral Glucose

Other: 75g Oral Glucose

Interventions

100g Standard Noodles OTHER

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

100g Standard Noodles

75g Oral Glucose OTHER

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

75g Oral Glucose

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200021, China

Location

Related Publications (1)

• 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.

  PMID: 40270326 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Guang Ning, MD,PHD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital

Study Record Dates

• First Submitted: September 29, 2013
• First Posted: October 10, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

CN (1)