Hypogonadotropic HypogonadismPhase 1/2NCT02154477

Effect of Intranasal Insulin on LH Concentrations in Man

A Phase 1/2 study testing intranasal insulin in people with Hypogonadotropic Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Hypogonadotropic Hypogonadism
What is being tested?: intranasal insulin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Dec 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

TTTUHSC-Permian Basin
Odessa, Texas, 79763

Other trials in United States

About this study

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.

Read the 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
Being tested: intranasal insulin, placebo (intranasal saline)
Keywords: hypogonadotropic hypogonadism
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intranasal insulinDrug
insulin
placebo (intranasal saline)Drug
saline

Study groups in NCT02154477
Study group	Role	What they receive
diabetes	Active comparator	All patient will receive insulin at one visit and saline at another visit Receives: Drug: intranasal insulin; Drug: placebo (intranasal saline)
control	Active comparator	All patient will receive insulin at one visit and saline at another visit Receives: Drug: intranasal insulin; Drug: placebo (intranasal saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

LH
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Dec 2017

First posted3 Jun 2014 (estimated)
Study startDec 2014
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02154477
Sponsor's protocol ID: L14-075
Status last verified: Jul 2019
First submitted: 30 May 2014
Last updated: 13 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 30515210

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
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All Hypogonadotropic Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Intranasal Insulin on LH Concentrations in Man
ClinicalTrials.gov ID: NCT02154477
Acronym / sponsor ID: L14-075
Conditions: Hypogonadotropic Hypogonadism
Keywords: hypogonadotropic hypogonadism
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Texas Tech University Health Sciences CenterUniversity, hospital or other
Study start: Dec 2014 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 13 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
diabetes	Active comparator	Drug: intranasal insulin, Drug: placebo (intranasal saline)All patient will receive insulin at one visit and saline at another visit
control	Active comparator	Drug: intranasal insulin, Drug: placebo (intranasal saline)All patient will receive insulin at one visit and saline at another visit

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intranasal insulininsulin	Drug	control, diabetes
placebo (intranasal saline)saline	Drug	control, diabetes

Primary outcome

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

Results and safety

Results posted to the registry on 13 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	6	6
Diabetes	8	8

Primary outcome: LH

Time frame: 4 hours. Mean (Standard Deviation). Unit: IU/L

Measure	Diabetes n = 8	Control n = 6
baseline	7.7 (3)	3.3 (1.4)
post-intervention saline	7.9 (4.3)	3.8 (1.4)
post-intervention insulin	8 (3.4)	3.4 (1.2)

Population analysed: diabetes

Adverse events

Time frame: 4 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetes	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Control	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30515210Dhindsa 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.
Individual participant dataSharing planned: No

Related trials for Hypogonadotropic Hypogonadism

Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
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AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandeep Dhindsa, MD principal investigator

TTUHSC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intranasal insulin in people with Hypogonadotropic Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LH (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02154477, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.