Clinical trial

Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

Opening soon · Phase 4 · 0 countries · Registry ID NCT07706088

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionNeuropathy, Small Fiber, Diabete Mellitus

Full registry criteria

Inclusion Criteria: Eligible participants (≥ 18 years) with diabetes duration of \< 10 years, baseline HbA1c between 7% and 10% Signs and symptoms of DSPN based on a Michigan Neuropathy Screening Instrument (MNSI) history composite score of \>= 7 OR MNSI examination SCORE \>= 2.5 will be enrolled. BMI \>= 27 KG/metre 2. Exclusion Criteria: 1. participants with untreated hypothyroidism 2. history of leprosy 3. peripheral vascular disease defined by ankle-brachial index (ABI) \< 0.9 4. serum B12 levels \< 200 pg./mL/ if low will be supplemented 5. history of alcohol excess (\>=2 and \>= 1 standard drink per day for male and female respectively) 6. any condition affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months or Sjogren\'s or sicca syndrome 7. use of oral contraceptives.

Treatments and study arms

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

Primary outcomes

To assess the percent change in CNFD compared to baseline6 months

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.