Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy

NCT03914404 | Completed Phase 4 DMC

• 1 other identifier: DLB-DN-EVOP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief Summary

This study was a 12-week, multi-center, randomized, double-blind, double dummy, parallel clinical trial to compare the efficacy of γ-linolenic acid and Thioctic acid in patients with diabetic neuropathy.

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• Changes of Visual Analog Scale(VAS)

  The Visual Analog Scale(VAS) score is 0 point for no symptom, 10 points for the most severe symptom, and the patient is asked to mark the degree of subjective pain symptoms as an integer.

  12 weeks

• Changes of Total Symptom Score(TSS)

  Total Symptom Score(TSS) classifies diabetic neuropathy symptoms into four categories (pain, burning pain, paresthesia, numbness). The frequency (Occasional, Frequent, Continuous) and symptom intensity (Absent, Slight, Moderate, Severe) are calculated through each question and the score is obtained according to the visual analog scale. It is calculated from 0 point up to 14.64 points.

  12 weeks

Secondary Outcomes (5)

• Changes of Michigan Neuropathy Screening Instrument(MNSIQ)

  12 weeks

• Changes of Michigan Neuropathy Screening Instrument(MNSIE)

  12 weeks

• Changes of Current perception Threshold(CPT)

  12 weeks

• Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN)

  12 weeks

• Changes of EuroQol-5 Dimensions(EQ 5D)

  12 weeks

Study Arms (2)

Test group

EXPERIMENTAL

* γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time. * Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.

Drug: γ-linoleic acid and placebo(Thioctic Acid)

Control Group

EXPERIMENTAL

* Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time. * γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.

Drug: Thioctic Acid and placebo(γ-linoleic acid)

Interventions

γ-linoleic acid and placebo(Thioctic Acid) DRUG

* γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time. * Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.

Test group

Thioctic Acid and placebo(γ-linoleic acid) DRUG

* Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time. * γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.

Control Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were between 20 years and 75 years at screening
• Patients who were diagnosed with type 2 diabetes and whose HbA1c levels were less than 11% at screening
• Patients with a score of 4 or more on the Visual Analogue Score(VAS)
• One or more of the following items
• If the physical examination score of the Michigan Neuropathy Screening Instrument Score (MNSI) is more than 2 points at the initial screening
• type 2 diabetic patient who complained one or more of pain, burning sensation, numbness, and sensory loss and measured the current perception threshold (CPT) of the peroneal nerve at three frequencies (2000Hz, 250Hz, 5Hz) Anyone whose diabetes mellitus has been diagnosed as diabetic neuropathy
• Patients who decided to voluntarily participate in clinical trials and agreed in writing

You may not qualify if:

• Peripheral neuropathy caused by other causes other than diabetes
• Those are suffering from other painful conditions that are so severe that diabetic neuropathy can not be assessed
• If you have a progressive or degenerative neurological disorder
• Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg
• Patients who were positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) test
• patients with liver dysfunction (ALT / AST\> 3 times the upper limit of normal)
• Patients with renal dysfunction (Serum creatine\> 2.0 mg / dl)
• Patients with thyroid dysfunction (Thyroid and anti-thyroid medications may be included in this study if they are maintained in normal state.)
• Patients with amputation (including toes) or infections of the lower extremities
• The following diseases are clinically significant patients
• Unstable coronary artery disease or peripheral vascular disease
• Liver, kidney, lung, hematologic disease
• Cancer (within 5 years if possible)
• Patients who have suicide attempts or suicidal tendencies and who have a psychiatric history within 6 months before starting the trial
• Patients with substance abuse or chronic alcohol abuse within 2 years prior to taking the test

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (11)

Sejong hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Obesity Research Center of Chonbuk National University

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Dongguk university gyeongju hospital

Gyeongju, North Gyeongsang-do, 38067, South Korea

Location

Soon chun hyang university hospital cheonan

Cheonan, South Chungcheong Province, 31151, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Gachon University Gil Medical Center

Incheon, 2156, South Korea

Location

Pusan National University Hospital

Pusan, 49241, South Korea

Location

Inje university sanggye paik hospital

Seoul, 01757, South Korea

Location

Yonsei univesity severance hospital

Seoul, 03722, South Korea

Location

The catholic university of korea seoul st. mary's hospital

Seoul, 06591, South Korea

Location

The catholic university of korea Yeouido st. mary's hospital

Seoul, 07345, South Korea

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Bong-Yeon Cha, MD,PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Jong hwa Kim, MD

  Sejong General Hospital

  PRINCIPAL INVESTIGATOR

• Lee-byeong Park, MD,PhD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• Hyuk Sang Kwon, MD,PhD

  The catholic university of korea Yeouido st. mary's hospital

  PRINCIPAL INVESTIGATOR

• In Joo Kim, MD,PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Ji hyun Lee, MD,PhD

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

• sung soo Moon, MD,PhD

  DongGuk University

  PRINCIPAL INVESTIGATOR

• Sung wan Chun, MD,PhD

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

• Byung-Wan Lee, MD,PhD

  Yonsei univesity severance hospital

  PRINCIPAL INVESTIGATOR

• Jong chul Won, MD,PhD

  Inje University

  PRINCIPAL INVESTIGATOR

• Tae-Sun Park, MD,PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obesity Research Center of Chonbuk National University

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: January 26, 2016
• Primary Completion: March 30, 2016
• Study Completion: July 25, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

KR (11)