Effect of Intranasal Insulin on LH Concentrations in Man

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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 glomerular filtration rate<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