drugset / Trial / NCT02154477

Effect of Intranasal Insulin on LH Concentrations in Man

NCT02154477

Phase 1/2 Completed 14 enrolled Texas Tech University Health Sciences Center
RandomizedCrossoverDouble-blindTreatment

Summary

Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones. Obesity and metabolic syndrome are also associated with HH. Research suggests that insulin in the brain may benefit the glands that release these hormones. During this study, subjects will spray a small amount of insulin into their nose.This will increase insulin concentrations in the brain. The purpose of this study is to find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in obese diabetic men with HH.

Timeline

Start
2014-12
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic 40 iu Intranasal