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Effect of Intranasal Insulin on LH Concentrations in Man

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ClinicalTrials.gov Identifier: NCT02154477
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Drug: intranasal insulin Drug: placebo (intranasal saline) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intranasal Insulin on LH Concentrations in Man
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: diabetes
All patient will receive insulin at one visit and saline at another visit
Drug: intranasal insulin
insulin

Drug: placebo (intranasal saline)
saline

Active Comparator: control
All patient will receive insulin at one visit and saline at another visit
Drug: intranasal insulin
insulin

Drug: placebo (intranasal saline)
saline




Primary Outcome Measures :
  1. LH [ Time Frame: 4 hours ]
    Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154477


Locations
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United States, Texas
TTTUHSC-Permian Basin
Odessa, Texas, United States, 79763
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Sandeep Dhindsa, MD TTUHSC
  Study Documents (Full-Text)

Documents provided by Texas Tech University Health Sciences Center:

Publications of Results:
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02154477     History of Changes
Other Study ID Numbers: L14-075
First Posted: June 3, 2014    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Texas Tech University Health Sciences Center:
hypogonadotropic hypogonadism
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs