Diabetes
Conditions
Interventions
oral meal tolerance:Eat instant noodles
intravenous glucose tolerance:Intravenous drip of 25% glucose
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All subjects were prohibited from smoking, drinking, and vigorous exercise at least one week before the clinical trial. The diet should contain at least 150 g of carbohydrates for three days before the clinical trial. a) Healthy subjects 1) Confirm the subjects by WHO diagnostic criteria. Healthy subjects: fasting blood glucose less than 6.1 mmol/L, two-hour blood glucose less than 7.8 mmol/L in oral glucose tolerance test. 2) HbA1c = 50kg, female weight >= 45kg and body mass index (BMI) 19-28 kg/m2 (inclusive), of which one gender is not less than one third; 5) Subjects voluntarily sign an informed consent form; 6) Subjects can maintain effective communication with investigators and comply with the requirements of clinical trials. b) Patients with impaired glucose tolerance 1) Confirm the subjects by WHO diagnostic criteria. Patients with impaired glucose tolerance: two-hour blood glucose >= 7.8 = 50 kg, female weight >= 45 kg and body mass index (BMI) 19-28 kg/m2 (inclusive), of which one gender is not less than one third; 5) Urinary microalbumin/creatinine = 7.0 mmol/L; two hours later, blood glucose >= 11.1 mmol/L in oral glucose tolerance test; 2) Fasting blood glucose >= 7.0 mmol/L and = 6.5% and = 50 kg, female weight >= 45 kg and body mass index (BMI) 19-28 kg/m2 (inclusive), of which one gender is not less than one third; 7) Urinary microalbumin/creatinine < 30 mg/g.cr, and the detection value of blood creatinine is within the normal range of 62~115 µmol/L; 8) Subjects voluntarily sign an informed consent form; 9) Subjects can maintain effective communication with investigators and comply with various requirements of clinical trials.
Exclusion criteria
Exclusion criteria: a) Healthy subjects and patients with impaired glucose tolerance 1) Smokers who consume more than 10 cigarettes or an equivalent amount of tobacco per day. Smokers cannot stop smoking during the trial; 2) Use any prescription drugs within 4 weeks before the trial, or use any over-the-counter drugs (vitamins, herbal tonics, food additives) within 2 weeks before the trial. Acetaminophen can be used; 3) Participated in clinical trials within three months before the trial; 4) Blood donation or blood loss >= 400mL within eight weeks before the trial; 5) Women during pregnancy or lactation; 6) History of abnormal ECG or family history of long QT syndrome (grandparents, parents and siblings); 7) History of gestational diabetes; 8) History of drug allergy or atopic disease (asthma, urticaria, eczema dermatitis), known to be allergic to test drugs (50% glucose injection) and instant noodles; 9) Any disease that may significantly affect glucose absorption, distribution, metabolism, and excretion or any disease may have a hazard to the subject within two weeks before the trial. The details of the disease are as follows, and the researcher judges based on clinical symptoms: a) History of inflammatory bowel disease, gastritis, ulcer, gastrointestinal or rectal bleeding; b) History of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, or bowel resection); c) Pancreatic injury or pancreatitis history or clinical evidence, or the researcher judges abnormal lipase and amylase; d) If a liver function (such as ALT, AST, serum bilirubin) is abnormal and judged to be of clinical significance, it indicates liver disease or liver damage. (Alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], transglutaminase [GGT], total bilirubin) are greater than their respective upper limits of normal ( ULN) 2 times); e) Have a history or evidence of renal insufficiency, clinically significant creatinine abnormalities or abnormal urine components (such as casts), or eGFR MDRD < 80 ml/min /1.73m2; the formula is: male 175 x blood creatinine^- 1.154 x Age^-0.203, Female 175 x Sera creatinine^-1.154 x Age^-0.203 x 0.742. The unit of blood creatinine is mg/dL and the unit of age in years. f) Urinary tract obstruction or difficulty in emptying urine during the screening period; 10) Any abnormality of clinically significant physical examination, vital signs, electrocardiogram, or clinical laboratory measurement results; 11) Human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis test positive; 12) There is a history of drug or alcohol abuse within 12 months before the trial or laboratory examinations found evidence of such abuse during the evaluation during the screening period; 13) During the screening, supine blood pressure (after 5 minutes of rest), systolic blood pressure exceeds 90~140mmHg (including 90,140), or diastolic blood pressure exceeds 50~90mmHg (including 50, 90), or heart rate (HR) exceeds 50bpm~100bpm (Including 50,100) range; 14) Researchers consider that they are not suitable for the trial; b) T2DM patients 1) Type 1 diabetes patients or a history of ketoacidosis: Fasting C-peptide <= 0.6 ng/mL (<= 0.20 nmol/L); 2) Patients with positive diabetes autoantibody test (Glutamate Decarboxylase Antibody GAD); 3) Have taken weight-loss drugs, niacin or glucocorticoid drugs in the past three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose;Serum Insulin;Serum C-peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic blood glucose monitoring;Blood glucose; | — |
Countries
China
Contacts
Public ContactDongyang Liu
Peking University Third Hospital
Outcome results
None listed