A Phase 1/2 interventional study of intranasal insulin and placebo (intranasal saline) in Hypogonadotropic Hypogonadism, sponsored by Texas Tech University Health Sciences Center. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Texas Tech University Health Sciences Center · Phase 1/2, Interventional, and Treatment
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.
Studies over the last few years have clearly established that at least 25% of men with type 2 diabetes have subnormal free testosterone (T) concentrations in association with inappropriately low leutinizing hormone (LH) and FSH (follicle stimulating hormone) concentrations. These patients thus suffer from hypogonadotrophic hypogonadism (HH). Obesity and metabolic syndrome are also associated with HH. Animal studies and in vitro data have shown that insulin action and insulin responsiveness in the brain are necessary for the maintenance of the functional integrity of the hypothalamo-hypophyseal-gonadal axis. Insulin concentrations can be increased in the brain by delivering insulin intranasally with vianase device. The aim of this project is to study the effect of one dose of intranasal insulin on release of LH in obese diabetic men with HH. 15 obese men with type 2 diabetes and low free T along with normal LH concentrations will be recruited for the study. The study will be carried out at the clinical center of Texas Tech (Odessa campus). There will be two study visits, each comprising of blood tests every 15 minutes over 6 hours. 40 IU of intranasal insulin or saline will be given after a baseline period of blood sampling of 2 hours. Student's t-test will be used to compare the change in LH concentrations after intranasal saline or insulin.
352 studies on the registry are indexed under Hypogonadism; 44 are open to participants now.
This study's enrollment of 14 is below the median of 55 across 265 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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All patient will receive insulin at one visit and saline at another visit
Drug: intranasal insulin · Drug: placebo (intranasal saline)
All patient will receive insulin at one visit and saline at another visit
Drug: intranasal insulin · Drug: placebo (intranasal saline)
insulin
saline
LH
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
Time frame: 4 hours
| Milestone | Control | Diabetes |
|---|---|---|
| Started | 6 | 8 |
| Completed | 6 | 8 |
| Not completed | 0 | 0 |
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
| IU/L | Diabetes | Control |
|---|---|---|
| baseline | 7.7 ± 3 | 3.3 ± 1.4 |
| post-intervention saline | 7.9 ± 4.3 | 3.8 ± 1.4 |
| post-intervention insulin | 8 ± 3.4 | 3.4 ± 1.2 |
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetes | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Diabetes | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 6 | 13 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Diabetes | Control | Total |
|---|---|---|---|
| Mean | 63 ± 7 | 30 ± 9 | 48 ± 18 |
| Sex: Female, Male(Participants) | Diabetes | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 6 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Diabetes | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 4 | 4 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Diabetes | Control | Total |
|---|---|---|---|
| United States | 8 | 6 | 14 |
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Plan to share: No
Ran from Dec 2014 to primary completion in Dec 2017, 36 months.
Results were first posted in Aug 2019, 1 year 8 months after primary completion.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin
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