Effect of Intranasal Insulin on LH Concentrations in Man
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/31/2017 |
| Start Date: | December 2014 |
| End Date: | December 2017 |
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.
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 homromone (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.
diabetes have subnormal free testosterone (T) concentrations in association with
inappropriately low leutinizing homromone (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.
Inclusion Criteria:
- Males age 18 to 75 years
- Obesity (BMI ≥30 kg/m2)
- Type 2 diabetes
- Hypogonadotropic hypogonadism defined as calculated free testosterone concentrations
below 7 ng/dl along with normal or low LH concentrations
Exclusion Criteria:
- HbA1c>8.5%
- Use of preprandial insulin therapy
- Use of testosterone currently or in the past 4 months
- Use of over the counter health supplements which contain androgens
- Use of corticosteroids or narcotics in the past 3 months
- Coronary event or procedure(myocardial infarction, unstable angina, coronary artery
bypass, surgery or coronary angioplasty) in the previous twelve weeks
- Type I Diabetes
- Currently suffering from foot ulcer, significant periodontal disease or any other
chronic infectious or inflammatory condition
- Hepatic disease (transaminase > 3 times normal) or cirrhosis
- Renal impairment (defined as GFR<30)
- HIV or Hepatitis C positive status
- Any other life-threatening, non-cardiac disease
- History of untreated severe obstructive sleep apnea(defined as apnea-hypopnea index
≥30)
- currently suffering from symptomatic depression, with or without treatment
- Use of an investigational agent or therapeutic regimen within 30 days of study
- Participation in any other concurrent clinical trial
- Pituitary tumor/damage/ other trophic hormone deficiency
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