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Effect of Intranasal Insulin on LH Concentrations in Man

Primary Purpose

Hypogonadotropic Hypogonadism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
intranasal insulin
placebo (intranasal saline)
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring hypogonadotropic hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • TTTUHSC-Permian Basin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

diabetes

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

LH
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms

Secondary Outcome Measures

Full Information

First Posted
May 30, 2014
Last Updated
July 23, 2019
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT02154477
Brief Title
Effect of Intranasal Insulin on LH Concentrations in Man
Official Title
Effect of Intranasal Insulin on LH Concentrations in Man
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism
Keywords
hypogonadotropic hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diabetes
Arm Type
Active Comparator
Arm Description
All patient will receive insulin at one visit and saline at another visit
Arm Title
control
Arm Type
Active Comparator
Arm Description
All patient will receive insulin at one visit and saline at another visit
Intervention Type
Drug
Intervention Name(s)
intranasal insulin
Intervention Description
insulin
Intervention Type
Drug
Intervention Name(s)
placebo (intranasal saline)
Intervention Description
saline
Primary Outcome Measure Information:
Title
LH
Description
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
Time Frame
4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Dhindsa, MD
Organizational Affiliation
TTUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
TTTUHSC-Permian Basin
City
Odessa
State/Province
Texas
ZIP/Postal Code
79763
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30515210
Citation
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.
Results Reference
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Effect of Intranasal Insulin on LH Concentrations in Man

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