Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

ConditionsNeuropathy, Small Fiber Diabete Mellitus

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration.

Using tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM / NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotrophic signalling.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

participants with untreated hypothyroidism

history of leprosy

peripheral vascular disease defined by ankle-brachial index (ABI) < 0.9

serum B12 levels < 200 pg./mL/ if low will be supplemented

Trial design

Design model

Parallel

Treatments tested in this trial

Tirzepatide 2.5mg weekly
Drug
tirzepatide will be initiated at 2.5 mg weekly and dose will be escalated to 7.5 mg weekly depending upon tolerance and changes in parameters from baseline as described as outcomes
all standard of care to diabetic patient besides tirzepatide
Drug
diabetic patient will receive all standard of care beside tirzepatide

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: patients with diabetic peripheral neuropathy to receive standard of care including tirzepatideExperimental treatment 1 intervention

Group B: diabetic patients recieving standard care without use of tirzepatideActive comparator 1 intervention

Trial outcomes

Primary outcomes

To assess the percent change in CNFD compared to baseline

Time frame

6 months

Secondary outcomes

corneal confocal microscopy

To assess the percent change in CNBD ,CNFL compared to baseline To assess change in parameters ( CMAP/ DL / CV for motor nerves) and parameters (SNAP/ DL / CV for sensory nerves ) as assessed by NCS To assess change in body composition , HbA1C , FBS AND PP compared to baseline To assess change in oxidative stress markers SOD and inflammatory markers IL-6 To assess change in peripheral nerve injury marker BDNF.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Post Graduate Institute of Medical Education and Research, Chandigarh

Lead sponsor

Source ClinicalTrials.gov

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