Skip to content

A systematic biological study on type II diabetes mellitus and its peripheral neuropathy

A systematic biological study on type II diabetes mellitus and its peripheral neuropathy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033921
Enrollment
Unknown
Registered
2020-06-17
Start date
2020-06-03
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

type II diabetes mellitus and its peripheral neuropathy complications

Interventions

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Health Group Randomly selected health examination patients from the health management center of our hospital, the subjects should meet the following requirements: 1) All patients with complete examination items and physical signs without obvious abnormality or anxiety syndrome but corresponding complications; 2) No special eating habits; 3) No previous history of mental illness; 4) No history of drug abuse or allergy; 5) No history of drinking; 6) Age 18-75. 2. Inclusion criteria for type II diabetes: 1) It is in accordance with the diagnostic criteria of type II 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 (126mg / dl), and the postprandial blood glucose is greater than or equal to 11.1mmol/l (200mg / dl); 2) Have a clear history of diabetes; 3) Aged >= 30, gender unlimited; 4) Clear consciousness, no mental retardation, able to communicate normally; 3. Inclusion criteria for type II diabetic peripheral neuropathy: 1) It is in accordance with the diagnostic criteria of type II diabetic peripheral neuropathy. The diagnostic criteria of type II diabetic peripheral neuropathy refer to EMG and clinical neurophysiology group of Neurology branch of Chinese Medical Association (guidance of experts on diagnosis and treatment management of diabetic peripheral neuropathy in basic level (2019)), and the clinical diagnosis refers to modified neurological disability score (MNDs) and vibration perception threshold Threshold (VPT), i.e. fasting blood glucose level >= 7.0 mmol / L, patients have severe peripheral sensory defects (>= 2 physical signs screening abnormalities, 5 items in total, i.e. needle pricking sensation test, temperature sensation test, vibration sensation test, tendon reflex test, touch pressure sensation test); 2) Have a clear history of diabetes; 3) Aged >= 30, gender unlimited;

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for type II diabetes: 1) blood glucose < 7.8 mmol / L (140 mg / dl) 2 hours after OGTT; 2) Transient hyperglycemia caused by other stress factors; 3) Severe cardiovascular, liver and kidney dysfunction; 2. Exclusion criteria for type II diabetic peripheral neuropathy: 1) Severe cardiovascular, cerebrovascular, hepatic and renal dysfunction; 2) HIV positive, pregnancy, cancer, serious infection; 3) Severe mental illness and cognitive dysfunction; 4) Acute complications of type II diabetes.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;HbA1c;diastolic pressure;systolic pressure;Postprandial blood glucose;triglycerides;total cholesterol;High density lipoprotein;Low density lipoprotein;

Countries

China

Contacts

Public ContactYubo Li

Tianjin Medical University

yaowufenxi001@sina.com+86 15332130770

Outcome results

None listed

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