NCT02154477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 13, 2019

Completed
Last Updated

August 13, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

May 30, 2014

Results QC Date

January 15, 2019

Last Update Submit

July 23, 2019

Conditions

Hypogonadotropic Hypogonadism

Keywords

hypogonadotropic hypogonadism

Outcome Measures

Primary Outcomes (1)

  • LH

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

    4 hours

Study Arms (2)

diabetes

ACTIVE COMPARATOR

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

Drug: intranasal insulinDrug: placebo (intranasal saline)

control

ACTIVE COMPARATOR

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

Drug: intranasal insulinDrug: placebo (intranasal saline)

Interventions

intranasal insulinDRUG

insulin

controldiabetes
placebo (intranasal saline)DRUG

saline

controldiabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TTTUHSC-Permian Basin

Odessa, Texas, 79763, United States

Location

Related Publications (1)

  • 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.

    PMID: 30515210RESULT

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Results Point of Contact

Title
sandeep dhindsa
Organization
SLU
dhindsa@slu.edu
314-977-4911

Study Officials

  • Sandeep Dhindsa, MD

    TTUHSC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 13, 2019

Results First Posted

August 13, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)