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Metabonomics of type II diabetes mellitus and its complications

Metabonomics of type II diabetes mellitus and its complications

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026802
Enrollment
Unknown
Registered
2019-10-22
Start date
2019-06-20
Completion date
Unknown
Last updated
2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II diabetes and its complications

Interventions

Sponsors

Tianjin University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactYubo Li

Tianjin University of traditional Chinese Medicine

yaowufenxi001@sina.com+86 15332130770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026