CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
intranasal insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02154477
NCT02154477Phase 2Completed

Effect of Intranasal Insulin on LH Concentrations in Man

Texas Tech University Health Sciences Center·interventional·Posted Jun 3, 2014·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating intranasal insulin and placebo (intranasal saline) for Hypogonadotropic Hypogonadism. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 3, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 12.1 years ago

Interventions

intranasal insulindrug

insulin

placebo (intranasal saline)drug

saline