Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

Insulin Sensitivity Clinical Trial

Official title:

Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847456
• Other study ID #: SFB 997 A01 WP7
• Status: Completed
• Phase: N/A
• First received: April 28, 2013
• Last updated: December 20, 2013
• Start date: April 2013

Study information

• Verified date: December 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Drug:
• human insulin as nasal spray

• Placebo

Locations

Country	Name	City	State
Germany	University of Tuebingen, Internal medicine IV	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minutes to 120 minutes post nasal spray	No
Secondary	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.	45 to 120 minutes post spray	No