The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

NCT06041399 | Unknown Phase 4

• 1 other identifier: Dbinbin
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; electromyography; blood parameters

Outcome Measures

Primary Outcomes (2)

• the severity of diabetic peripheral neuropathy

  The nerve conduction examination was conducted at a room temperature of 24℃, with the legs warmed using an electric heating pad for at least 10 minutes to achieve a skin temperature of 32-35℃. The nerve conduction velocities and nerve conduction amplitudes were measured for both sides of the upper and lower limbs, including motor and sensory branches of the median nerve; motor and sensory branches of the ulnar nerve; motor branch of peroneal nerve; motor branch of the tibial nerve; sensory branch of the superficial peroneal nerve. In addition, both sides of the tibial nerve F-wave were recorded, and the lower one was regarded as the final F-wave. Slowed/blocked nerve conduction was defined as more than 2.5 standard deviation below the control nerve conduction threshold. Nerve conduction is defined as abnormal when two or more nerve abnormalities are detected.

  From admission to discharge, up to 1 week

• the presence of diabetic peripheral neuropathy

  When any of the elements of the screening process -- symptoms, signs, or abnormal nerve conduction parameters --was abnormal, medical records would be scrutinized to see if these participants had accepted a previous diabetic peripheral neuropathy diagnosis by a specialist.

  From admission to discharge, up to 1 week

Study Arms (4)

diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.

EXPERIMENTAL

Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.

Drug: hypoglycemic Agents(metformin); Drug: lipid-lowering drug(Statin)

diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.

NO INTERVENTION

Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.

Diabetic group with hypoglycemic or lipid-lowering drugs.

EXPERIMENTAL

Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs.

Drug: hypoglycemic Agents(metformin); Drug: lipid-lowering drug(Statin)

Diabetic group without hypoglycemic or lipid-lowering drugs.

NO INTERVENTION

Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group.

Interventions

hypoglycemic Agents(metformin) DRUG

patients treated with hypoglycemic Agents(metformin)

Diabetic group with hypoglycemic or lipid-lowering drugs.; diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.

lipid-lowering drug(Statin) DRUG

patients treated with lipid-lowering drug(Statin)

Diabetic group with hypoglycemic or lipid-lowering drugs.; diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who had undergone nerve conduction examination by electromyography(EMG).

You may not qualify if:

• pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
• patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
• parathyroid diseases (including hyperthyroidism and hypothyroidism);
• pancreatitis, pancreatectomy or any transplant;
• patients with malignancy and any serious concomitant disease limit the existence of life expectancy

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Central Study Contacts

Binbin Deng, Doctor

CONTACT

86-13695720610; dbinbin@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: September 18, 2023
• Study Start: February 1, 2012
• Primary Completion: December 18, 2022
• Study Completion: January 2, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-08

Locations

CN (1)