NCT06293664

Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes

Randomized Cross-over Designed Study of the Physiological Impact of Alpha MSH on Glycemic Response to an Oral Glucose Tolerance Test in Patients With Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Dasman Diabetes Institute · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM).

Detailed description

Pre-clinical studies in mice have shown improved glucose clearance with α-MSH infusion, particularly in skeletal muscle. Research has demonstrated that α-MSH improves glucose tolerance in healthy humans by promoting glucose uptake in skeletal muscle cells. Therefore this study seeks to answer the question of whether alpha-MSH improves glucose tolerance in patients with T2DM. This will be addressed through measuring the impact of α-MSH infusion in patients with T2DM. The research involves a double-blinded, randomized, placebo-controlled crossover study.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	α-MSH infusion	Pharmaceutical grade α-MSH is custom synthesized to GMP standards by Auspep (Australia www.auspep.com.au), a good manufacturing practice (GMP) accredited manufacturer of peptides, approved by the Therapeutic Goods Administration (TGA), European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
OTHER	Placebo solutions	Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Kuwait