Trial · Interventional

Status unknownNot applicableRegistry data

Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

NCTNCT04137328Other id358106

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Not applicable
Enrollment: 60 participants (estimated)
Sponsor: Fudan University · Other
Design: Randomized · Double masking
Countries: Not stated
Start: 30 Nov 2019 (estimated)
Primary completion: 30 Nov 2022 (estimated)
Completion: 30 Nov 2022 (estimated)
First posted: 24 Oct 2019
Last update posted: 25 Oct 2019
Conditions: Diabetic Neuropathic Pain

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020202120222023

N/A
Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide
NCT04137328
est. 30 Nov 2019 to est. 30 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
insulinDrug

Arms2

Experimental
liraglutide group
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.
Active comparator
control group
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Numerical pain scale (NRS)
Time frame · 3 months
Registry description
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.

Secondary outcomes(2)

Neurological symptom score (NSS) / neurological deficit score (NDS)
Time frame · 3 months
Registry description
Clinical diagnosis criteria of diabetic neuropathy: NDS score ≥ 6 points or NDS score 3-5 points with NSS score ≥ 5 points
Examination of nerve conduction function
Time frame · 3 months
Registry description
The examination of nerve conduction function was completed by professional doctors of EMG room using EMG evoked potential instrument. During the test, the patient was relaxed and lying in a quiet room, and the skin temperature was maintained at 32 ℃ \~ 33 ℃. Motor nerve examination includes: measurement of motor nerve conduction velocity, compound muscle action potential amplitude and distal latency of median nerve, ulnar nerve, common peroneal nerve and tibial nerve; sensory nerve examination includes: measurement of sensory nerve conduction velocity and action potential amplitude of median nerve, ulnar nerve, superficial peroneal nerve and sural nerve.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Animal study · 2017

18 results

The GLP-1 analogue lixisenatide decreases atherosclerosis in insulin-resistant mice by modulating macrophage phenotype.

Á et al. 2017Diabetologiacited by 118

PMID 28608285DOI 10.1007/s00125-017-4330-3PUB-28608285

Rights unknown18 results

Source link See results (18)

More studies

2 studies on this page

PubMed tag: none · 2017

Liraglutide dictates macrophage phenotype in apolipoprotein E null mice during early atherosclerosis.

Bruen et al. 2017Cardiovascular diabetologycited by 66

PMID 29110715PMC5674826DOI 10.1186/s12933-017-0626-3PUB-29110715

CC BY

Download PDF

Indexing hint: Review · 2016

Anti-atherogenic and anti-inflammatory properties of glucagon-like peptide-1, glucose-dependent insulinotropic polypepide, and dipeptidyl peptidase-4 inhibitors in experimental animals.

Hirano et al. 2016Journal of diabetes investigationcited by 46

PMID 27186361PMC4854510DOI 10.1111/jdi.12446PUB-27186361

Free to read · publisher termsCC BY-NC

Read at source

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 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. Exclusion Criteria: 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.

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