Neuropathic Pain and Type II Diabetic Patients

NCT06798181 | Recruiting

• 1 other identifier: Burcu Bayrak 3
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients. Diabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities. In diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.

Conditions

Quality of Life; Neuropathic Pain; Diabetic Neuropathies

Outcome Measures

Primary Outcomes (2)

• Neuropathic pain

  Self-Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) will be used to assess neuropathic pain types. When the score obtained from this scale consisting of 7 items is \>12, neuropathic pain is diagnosed.

  15/12/2024-30/07/2025

• the pain severity

  As the first outcome of the study, the patients' neuropathic pain status and pain intensity will be determined. The following scales will be used for this. VAS-Visual Analog Scale will be used to assess pain. Scoring will be between 0-10.

  15/12/2024-30/07/2025

Secondary Outcomes (2)

• Quality of life will be measured with the Diabetes Quality of Life (DQOL) scale

  15/12/2024-30/07/2025

• the Self-Care Agency Scale

  15/12/2024-30/07/2025

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals over the age of 18 diagnosed with Type II diabetes

You may qualify if:

• years and older,
• Diagnosed with type II diabetes,
• Reading and writing,
• No physical or psychological communication barriers,
• Can read and speak Turkish,
• Volunteers

You may not qualify if:

• Diagnosed with type I diabetes

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Seyh Edeabli University

Bilecik, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neuralgia; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Burcu Bayrak Kahraman, PhD

CONTACT

+905057542411; burcu.bayrak@bilecik.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 29, 2025
• Study Start: December 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: January 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2024-12

Locations

TU (1)