Metabonomics of type II diabetes mellitus and its complications

Not Applicable

Recruiting

• Conditions: Type II diabetes and its complications

• Registration Number: ITMCTR1900002700
• Lead Sponsor: Tianjin University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Early inclusion criteria for type II diabetes:
(1) meet the criteria of early diagnosis of type 2 diabetes. Early clinical diagnosis of diabetes refers to the American Diabetes Association criteria, that is, impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). IFG was defined as fasting blood glucose level of 100-125 mg / dl, and IGT was defined as blood glucose level of 140-199 mg / dl 2 hours after meal in OGTT test. The HbA1c level was between 5.7% and 6.4%, and early diabetic patients could also be identified;
(2) the age is between 30-80 years old, and the gender is not limited;
(3) clear consciousness, no intellectual obstacle, able to communicate normally;
(4) all of them were informed of the study and participated in it voluntarily.
II inclusion criteria for diabetes:
(1) meet the diagnostic criteria of diabetes. The clinical diagnosis of type II diabetes refers to the American Diabetes Association criteria, that is, the fasting blood glucose level is greater than or equal to 7.0 mmol/L, and the postprandial blood glucose is greater than or equal to 11.1 mmol/L;
(2) diabetes history of more than 1 year;
(3) the age is between 30-80 years old, and the gender is not limited;
(4) clear consciousness, no intellectual obstacle, able to communicate normally;
(5) all of them were aware of this study and participated in it voluntarily.
Inclusion criteria for type II diabetic ketosis:
(1) it meets the diagnostic standard of clinical type II diabetic ketosis. The clinical diagnosis of type II diabetic ketosis refers to the American Diabetes Association criteria, i.e. the whole blood pH is less than 7.30 or the serum bicarbonate level is less than 18mmol/L, and the blood glucose level is more than 11mmol/L. the urine ketosis is positive by routine urine examination;
(2) diabetes history of more than 1 year;
(3) the age is between 30-80 years old, and the gender is not limited;
(4) clear consciousness, no intellectual obstacle, able to communicate normally;
(5) all of them were aware of this study and participated in it voluntarily.
Inclusion criteria for type II diabetic retinopathy:
(1) it is in accordance with the diagnostic standard of clinical type II diabetic retinopathy. The clinical diagnosis of type II diabetic retinopathy refers to the American Diabetes Association criteria, that is, the fasting blood glucose level is more than or equal to 7.0 mmol/L, and at least one eye is diagnosed as diabetic retinopathy by fundoscopy, fundus color photography and angiography. The diagnosis of nonproliferative diseases is based on spot hemorrhage, microarterial tumor, tampon spot or microvascular abnormality in retina, while the diagnosis of proliferative diseases is based on the presence of iris or retinal neovascularization;
(2) diabetes history of more than 1 year;
(3) the age is between 30-80 years old, and the gender is not limited;
(4) clear consciousness, no intellectual obstacle, able to communicate normally;
(5) all of them were aware of this study and participated in it voluntarily.
Inclusion criteria of type II diabetic nephropathy:
(1) it conforms to the diagnostic standard of clinical type II diabetic nephropathy. For the clinical diagnosis of type II diabetic retinopathy, please refer to the American Diabetes Association criteria, i.e. urinary albumin > 300mg / 24h or estimated glomerular filtration rate EGFR < 60ml / min / 1.73m2;
(2) diabetes history of more than 1 year;
(3) the age is b

Exclusion Criteria

Exclusion criteria for impaired glucose tolerance:
(1) transient hyperglycemia caused by other stress factors;
(2) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(3) HIV positive, pregnancy, cancer, serious infection;
(4) severe mental illness and cognitive impairment.
II exclusion criteria for diabetes:
(1) normal blood glucose: fasting blood glucose <5.6 mmol/L, 2 hours after OGTT blood glucose <7.8 mmol/L;
(2) transient hyperglycemia caused by other stress factors;
(3) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(4) HIV positive, pregnancy, cancer, serious infection;
(5) severe mental illness and cognitive impairment;
(6) those diagnosed as type 1 diabetes;
(7) no acute complications of type 2 diabetes.
Exclusion criteria for type II diabetic ketosis:
(1) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(2) patients with HIV positive, pregnancy, cancer and serious infection;
(3) severe mental illness and cognitive impairment;
(4) those diagnosed as type 1 diabetic ketosis.
Exclusion criteria of diabetic retinopathy type II:
(1) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(2) patients with HIV positive, pregnancy, cancer and serious infection;
(3) severe mental illness and cognitive impairment;
(4) those diagnosed as type 1 diabetic retinopathy;
(5) large area of fibrovascular membrane pulling macular edema;
(6) rhegmatogenous or traction retinal detachment;
(7) have a history of eye injury;
(8) complicated with uveitis, glaucoma and conjunctivoscleral scar;
(9) there were no acute complications of type II diabetes.
Exclusion criteria for type II diabetic nephropathy:
(1) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(2) patients with HIV positive, pregnancy, cancer and serious infection;
(3) severe mental illness and cognitive impairment;
(4) those diagnosed as type 1 diabetic nephropathy;
(5) patients with primary kidney disease;
(6) there were no acute complications of type II diabetes.
Exclusion criteria for type II diabetic foot disease:
(1) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(2) patients with HIV positive, pregnancy, cancer and serious infection;
(3) severe mental illness and cognitive impairment;
(4) the patient was diagnosed as type 1 diabetic foot disease;
(5) there are stress states such as infection outside the operation or serious foot disease site;
(6) there were no acute complications of type II diabetes.
Exclusion criteria of type II diabetic peripheral neuropathy:
(1) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(2) patients with HIV positive, pregnancy, cancer and serious infection;
(3) severe mental illness and cognitive impairment;
(4) those diagnosed as type 1 diabetic peripheral neuropathy;
(5) peripheral neuropathy caused by non type II diabetes mellitus (such as intervertebral disc disease or spinal nerve root disease, etc.);
(6) there were no acute complications of type II diabetes.
Exclusion criteria of healthy control group:
(1) have a clear history of diabetes;
(2) severe cardiovascular, cerebrovascular, hepatic and renal dysfunction;
(3) patients with HIV positive, pregnancy, cancer and serious infection;
(4) severe mental illness and cognitive impairment.

Study & Design

• Study Type: Basic Science
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AST;eGFR;systolic pressure;urinary albumin;Postprandial blood glucose;Urea nitrogen;HbA1c;LDH;CK-MB;Serum creatinine;CK;Fasting blood glucose;ALT;diastolic pressure;