Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy

NCT04638556 | Unknown

• 1 other identifier: 201940362
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to use high-throughput sequencing, molecular biology and bioinformatics technology to clarify the role of target lncrnas in the inflammatory response of DPN, to explore the correlation between target lncrnas and DPN pathogenesis, and to clarify the feasibility of target lncrnas as a marker of DPN cycle.

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetic peripheral neuropathy; long non-coding RNA; microRNA-146a; inflammation

Outcome Measures

Primary Outcomes (1)

• Nerve conduction velocity

  NCV was measured in the sural nerve. For the determination of motor nerve conduction velocity(MNCV), the sciatic nerve was stimulated with single supramaximal square wave pulses(5to10 Ma and 40μs duration) via fine needle electrodes inserted percutaneously.The distance between the two sites of stimulation was 2mm. MNCV was calculated by subtracting the distal latency from the proximal latency,and the result was divided into the distance between the stimulating and recording electrode.Sensory nerve conduction velocity(SNCV) was meaured and recorded.The site of stimulation was located in the ankle and the recording site was in the sciatic notch.The maximal SNCV was calculated by measuring the latency to the onset/peak of the initial negative deflection and the distance between stimulating and recording electrodes,and the result was divided by latency period.

  2020.09-2022.12

Study Arms (3)

Normal

A healthy, disease-free population.

Diagnostic Test: lncRNA detection

T2DM

T2DM group was simple type 2 diabetes mellitus.

Diagnostic Test: lncRNA detection

DPN

The screening criteria for T2DM patients with DPN are as follows: 1. Clear history of type 2 diabetes mellitus. 2. Neuropathy at or after the diagnosis of diabetes. 3. The clinical symptoms and signs were consistent with those of DPN. Clinical symptoms include: numbness or sensation; tingling or tingling; pain; abnormal sensitivity or tenderness after touching. 4. Examination: A. abnormal temperature sense; B. 10 g nylon thread examination, foot sensation decreased or disappeared; C. abnormal vibration sense; D. ankle reflex disappeared; e. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement). 5. Nerve injury caused by other diseases or drugs was excluded. Two of the above five items were abnormal, or clinical symptoms + 1 item were abnormal.

Diagnostic Test: lncRNA detection

Interventions

lncRNA detection DIAGNOSTIC_TEST

The lncRNAs in the plasma of three groups of patients will be tested.

DPN; Normal; T2DM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The normal group is healthy adults without any diseases. The T2DM group included patients with simple type 2 diabetes without complications of type 2 diabetes and other underlying diseases. The DPN group included patients with simple T2DM combined with DPN.

You may qualify if:

• Healthy Volunteers

You may not qualify if:

• Peripheral neuropathy
• The T2DM group
• Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Patients who decided to voluntarily participate in clinical trials and agreed in writing
• Patients with diabetic complication Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg Patients with other disease
• The DPN group
• Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Neuropathy at or after the diagnosis of diabetes Clinical symptoms include: numbness or sensation, tingling or tingling, pain, abnormal sensitivity or tenderness after touching
• Examination item include:
• abnormal temperature sense
• g nylon thread examination, foot sensation decreased or disappeared
• abnormal vibration sense
• ankle reflex disappeared
• two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement) Patients with two of the above five items were abnormal, or patients with clinical symptoms plus 1 item
• Nerve injury caused by other diseases or drugs Patients with T1DM or other endocrine system diseases, acute complications of diabetes, such as diabetic ketoacidosis and hypertonic non ketotic coma, cardiovascular and cerebrovascular diseases, nonalcoholic fatty liver disease, liver and kidney failure, inflammatory diseases, active infection, cancer, pregnancy or lactation Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg In addition to the above items, patients who are deemed inappropriate by clinical trial researchers

Sponsors & Collaborators

• Jinshan Hospital Fudan University: lead
• Shanghai Municipal Commission of Health and Family Planning: collaborator

Study Sites (1)

Jinshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

An Qi, undergraduate

CONTACT

86+021-57039818; jsyyllwyh2018@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: September 3, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)