Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

NCT04137328 | Unknown

• 1 other identifier: 358106
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetic neuropathic pain is a common clinical manifestation of diabetic neuropathy, which seriously affects the quality of life of patients. The clinical treatment is limited and the curative effect is not good. In the previous animal studies, investigators found that the change of pain threshold in diabetic rats showed a staged change, and was significantly related to the change of brain microglia activity. It was confirmed that liraglutide could regulate the activation of microglia in vitro. Then investigators found that it could intervene diabetic neuropathic pain through the intervention of liraglutide in diabetic rats. In the early stage of clinical observation, the investigators also preliminarily observed that liraglutide can intervene diabetic neuropathic pain. At present, liraglutide is a commonly used hypoglycemic drug in clinic. Therefore, on the basis of previous studies, this study intends to select diabetic neuropathic pain patients whose blood sugar is not up to the standard, and give Mecobalamin to treat diabetic neuropathy. In addition, on the basis of the original hypoglycemic treatment, participants are randomly divided into one group to give liraglutide, one group to increase or adjust insulin, with similar blood glucose level. The improvement of diabetic neuropathic pain was observed. The aim of this study was to evaluate the safety and efficacy of liraglutide in improving diabetic neuropathic pain.

Conditions

Diabetic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Numerical pain scale (NRS)

  The number of 0-10 represents the degree of pain of the patient, 0 is no pain, 10 is extreme pain. How to write: circle the number that describes the most severe pain in the last 24 hours.

  3 months

Secondary Outcomes (2)

• Neurological symptom score (NSS) / neurological deficit score (NDS)

  3 months

• Examination of nerve conduction function

  3 months

Study Arms (2)

liraglutide group

EXPERIMENTAL

Mecobalamin tablets (0.5mg/day, oral) and liraglutide (0.6mg/day in the first week, if there is no obvious discomfort, 1.2mg/day in the second week, subcutaneous injection) were used for 3 months.

Drug: Liraglutide

control group

ACTIVE COMPARATOR

Take Mecobalamin (0.5mg/day, oral), add or adjust insulin (when basic insulin is preferred for those who do not use insulin, if insulin has been used, adjust the dose or program according to the condition, inject subcutaneously) for 3 months.

Drug: insulin

Interventions

Liraglutide DRUG

0.6mg/day in the first week, if there is no obvious discomfort, 1.2mg/day in the second week, subcutaneous injection, lasting for 3 months

Also known as: GLP-1RA

liraglutide group

insulin DRUG

Add or adjust insulin (when basic insulin is preferred for those who do not use insulin, such as those who have already used insulin, adjust the dosage or program according to the condition, inject subcutaneously) for 3 months

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80; The patients were diagnosed as type 2 diabetic neuropathic pain, and the score of pain digital scoring method was more than 3 points; 7-9% of glycosylated hemoglobin had poor blood glucose control.

You may not qualify if:

• Non diabetic neuropathic pain; BMI \< 20kg / m2; There are serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system; In the past 1 month, there were acute complications such as diabetic ketoacidosis, lactic acidosis and hyperosmotic coma; Over the past five years, there have been alcoholics and / or psychoactive substances, drug abusers and addicts; Pregnant or lactating women; Unwillingness to cooperate or various factors affecting compliance; Psychopaths; Those who have participated in other clinical projects in the past 1 month.

Sponsors & Collaborators

• Fudan University: lead

Related Publications (10)

• Jeffcoate WJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcers. Diabetes Care. 2018 Apr;41(4):645-652. doi: 10.2337/dc17-1836.

  PMID: 29559450 BACKGROUND

• Lu B, Yang Z, Wang M, Yang Z, Gong W, Yang Y, Wen J, Zhang Z, Zhao N, Zhu X, Hu R. High prevalence of diabetic neuropathy in population-based patients diagnosed with type 2 diabetes in the Shanghai downtown. Diabetes Res Clin Pract. 2010 Jun;88(3):289-94. doi: 10.1016/j.diabres.2010.02.002. Epub 2010 Mar 31.

  PMID: 20359765 BACKGROUND

• Kanera IM, van Laake-Geelen CCM, Ruijgrok JM, Goossens MEJB, de Jong JR, Verbunt JA, Geerts M, Smeets RJEM, Kindermans HPJ. Living with painful diabetic neuropathy: insights from focus groups into fears and coping strategies. Psychol Health. 2019 Jan;34(1):84-105. doi: 10.1080/08870446.2018.1518526. Epub 2018 Oct 15.

  PMID: 30320508 BACKGROUND

• Tsuda M. Microglia in the spinal cord and neuropathic pain. J Diabetes Investig. 2016 Jan;7(1):17-26. doi: 10.1111/jdi.12379. Epub 2015 Jun 23.

  PMID: 26813032 BACKGROUND

• Inoue K, Tsuda M. Microglia in neuropathic pain: cellular and molecular mechanisms and therapeutic potential. Nat Rev Neurosci. 2018 Mar;19(3):138-152. doi: 10.1038/nrn.2018.2. Epub 2018 Feb 8.

  PMID: 29416128 BACKGROUND

• Hirano T, Mori Y. Anti-atherogenic and anti-inflammatory properties of glucagon-like peptide-1, glucose-dependent insulinotropic polypepide, and dipeptidyl peptidase-4 inhibitors in experimental animals. J Diabetes Investig. 2016 Apr;7 Suppl 1(Suppl 1):80-6. doi: 10.1111/jdi.12446. Epub 2016 Mar 31.

  PMID: 27186361 BACKGROUND

• Bruen R, Curley S, Kajani S, Crean D, O'Reilly ME, Lucitt MB, Godson CG, McGillicuddy FC, Belton O. Liraglutide dictates macrophage phenotype in apolipoprotein E null mice during early atherosclerosis. Cardiovasc Diabetol. 2017 Nov 6;16(1):143. doi: 10.1186/s12933-017-0626-3.

  PMID: 29110715 BACKGROUND

• Vinue A, Navarro J, Herrero-Cervera A, Garcia-Cubas M, Andres-Blasco I, Martinez-Hervas S, Real JT, Ascaso JF, Gonzalez-Navarro H. The GLP-1 analogue lixisenatide decreases atherosclerosis in insulin-resistant mice by modulating macrophage phenotype. Diabetologia. 2017 Sep;60(9):1801-1812. doi: 10.1007/s00125-017-4330-3. Epub 2017 Jun 12.

  PMID: 28608285 BACKGROUND

• Lee CH, Jeon SJ, Cho KS, Moon E, Sapkota A, Jun HS, Ryu JH, Choi JW. Activation of Glucagon-Like Peptide-1 Receptor Promotes Neuroprotection in Experimental Autoimmune Encephalomyelitis by Reducing Neuroinflammatory Responses. Mol Neurobiol. 2018 Apr;55(4):3007-3020. doi: 10.1007/s12035-017-0550-2. Epub 2017 Apr 29.

  PMID: 28456941 BACKGROUND

• Barros JI, Fechine FV, Montenegro Junior RM, Vale OC, Fernandes VO, Souza MH, Cunha GH, Moraes MO, d'Alva CB, Moraes ME. Effect of treatment with sitagliptin on somatosensory-evoked potentials and metabolic control in patients with type 2 diabetes mellitus. Arq Bras Endocrinol Metabol. 2014 Jun;58(4):369-76. doi: 10.1590/0004-2730000002914.

  PMID: 24936731 BACKGROUND

MeSH Terms

Interventions

Liraglutide; Insulin

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Bin Lu, doctor

  Huashan Hospital

  STUDY DIRECTOR

Central Study Contacts

Bin Lu, doctor

CONTACT

18121186716; lubinfd@126.com

Qi Zhang

CONTACT

8618817872010; zhangqi_fudan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: November 30, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share