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Not Yet Recruiting NCT07706088

Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

Conditions: Neuropathy, Small Fiber, Diabete Mellitus

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Summary

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

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) \&lt; 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\&#39;s or sicca syndrome 7. use of oral contraceptives.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07706088). StuddyBuddy aggregates publicly available trial information.