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Trial record 1 of 6 for:    "Hypogonadotropic Hypogonadism" | "insulin"
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypogonadotropic Hypogonadism
Interventions Drug: intranasal insulin
Drug: placebo (intranasal saline)
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Diabetes
Hide Arm/Group Description lean healthy men, randomized to receive saline or insulin at first visit and the alternate treatment at second visit men with diabetes, randomized to receive saline or insulin at first visit and the alternate treatment at second visit
Period Title: Overall Study
Started 6 8
Completed 6 8
Not Completed 0 0
Arm/Group Title Diabetes Control Total
Hide Arm/Group Description

All patients will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit

intranasal insulin

placebo (intranasal saline)

All control subjects will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit

intranasal insulin

placebo (intranasal saline)

Total of all reporting groups
Overall Number of Baseline Participants 8 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
6
 100.0%
13
  92.9%
>=65 years
1
  12.5%
0
   0.0%
1
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 14 participants
63  (7) 30  (9) 48  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
6
 100.0%
14
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Hispanic or Latino
4
  50.0%
2
  33.3%
6
  42.9%
Not Hispanic or Latino
4
  50.0%
4
  66.7%
8
  57.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 14 participants
8 6 14
1.Primary Outcome
Title LH
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
diabetes
Arm/Group Title Diabetes Control
Hide Arm/Group Description:

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

intranasal insulin

placebo (intranasal saline)

lean healthy men. All men will receive insulin at one visit and saline at the other.
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: IU/L
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)
Time Frame 4 hours
Adverse Event Reporting Description hypoglycemia
 
Arm/Group Title Diabetes Control
Hide Arm/Group Description

All diabetes patients were randomized to receive either insulin or saline at one visit and the alternate treatment at the second visit.

intranasal insulin

placebo (intranasal saline)

All control subjects were randomized to receive either insulin or saline at one visit and the alternate treatment at the second visit.

intranasal insulin

placebo (intranasal saline)

All-Cause Mortality
Diabetes Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diabetes Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diabetes Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: sandeep dhindsa
Organization: SLU
Phone: 314-977-4911
EMail: dhindsa@slu.edu
Layout table for additonal information
Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02154477     History of Changes
Other Study ID Numbers: L14-075
First Submitted: May 30, 2014
First Posted: June 3, 2014
Results First Submitted: January 15, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019