Effect of Intranasal Insulin on LH Concentrations in Man

NCT ID: NCT02154477

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed Description

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.

Conditions

Hypogonadotropic Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

diabetes

All patient will receive insulin at one visit and saline at another visit

Group Type: ACTIVE_COMPARATOR

intranasal insulin

Intervention Type: DRUG

insulin

placebo (intranasal saline)

Intervention Type: DRUG

saline

control

All patient will receive insulin at one visit and saline at another visit

Group Type: ACTIVE_COMPARATOR

intranasal insulin

Intervention Type: DRUG

insulin

placebo (intranasal saline)

Intervention Type: DRUG

saline

Interventions

intranasal insulin

insulin

Intervention Type: DRUG

placebo (intranasal saline)

saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandeep Dhindsa, MD

Role: PRINCIPAL_INVESTIGATOR

TTUHSC

Locations

TTTUHSC-Permian Basin

Odessa, Texas, United States

Countries

United States

References

Dhindsa S, Chemitiganti R, Ghanim H, Santiago E, Haider A, Chaar N, Mok M, McKee A, Dandona P. Intranasal Insulin Administration Does Not Affect LH Concentrations in Men with Diabetes. Int J Endocrinol. 2018 Oct 31;2018:6170154. doi: 10.1155/2018/6170154. eCollection 2018.

Reference Type: RESULT

PMID: 30515210 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

L14-075

Identifier Type: -

Identifier Source: org_study_id