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Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

Primary Purpose

Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
human insulin as nasal spray
Placebo
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Sensitivity focused on measuring whole body insulin sensitivity, insulin action in the brain

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI < 28 kg/m2
  • normal HbA1c
  • healthy volunteers

Exclusion Criteria:

  • Heparin induced thrombocytopenia (HIT)
  • metal implants
  • cardial diseases
  • anemia
  • patients taking any kind of drugs

Sites / Locations

  • University of Tuebingen, Internal medicine IV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

insulin nasal spray

Placebo nasal spray

Arm Description

160 Units of human insulin as nasal spray

Nasalspray containing placebo solution

Outcomes

Primary Outcome Measures

Insulin sensitivity as measured by clamp
We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.

Secondary Outcome Measures

Autonomous nervous system activity
Activity of the autonomous nervous system will be estimated by heart rate variability in ECG. We will compare the post-spray autonomous nervous system activity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare autonomous nervous system activity before and after nasal insulin application.

Full Information

First Posted
April 28, 2013
Last Updated
December 20, 2013
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01847456
Brief Title
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
Official Title
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

Brief Summary
The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
Keywords
whole body insulin sensitivity, insulin action in the brain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin nasal spray
Arm Type
Experimental
Arm Description
160 Units of human insulin as nasal spray
Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Nasalspray containing placebo solution
Intervention Type
Drug
Intervention Name(s)
human insulin as nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Insulin sensitivity as measured by clamp
Description
We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.
Time Frame
45 minutes to 120 minutes post nasal spray
Secondary Outcome Measure Information:
Title
Autonomous nervous system activity
Description
Activity of the autonomous nervous system will be estimated by heart rate variability in ECG. We will compare the post-spray autonomous nervous system activity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare autonomous nervous system activity before and after nasal insulin application.
Time Frame
45 to 120 minutes post spray

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI < 28 kg/m2 normal HbA1c healthy volunteers Exclusion Criteria: Heparin induced thrombocytopenia (HIT) metal implants cardial diseases anemia patients taking any kind of drugs
Facility Information:
Facility Name
University of Tuebingen, Internal medicine IV
City
Tuebingen
ZIP/Postal Code
72074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25028522
Citation
Heni M, Wagner R, Kullmann S, Veit R, Mat Husin H, Linder K, Benkendorff C, Peter A, Stefan N, Haring HU, Preissl H, Fritsche A. Central insulin administration improves whole-body insulin sensitivity via hypothalamus and parasympathetic outputs in men. Diabetes. 2014 Dec;63(12):4083-8. doi: 10.2337/db14-0477. Epub 2014 Jul 15.
Results Reference
derived

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Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

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