Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

Not Applicable

Completed

• Conditions: Insulin Sensitivity
• Interventions: Drug: human insulin as nasal spray; Drug: Placebo

• Registration Number: NCT01847456
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-28
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-06
• Primary Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
insulin nasal spray	human insulin as nasal spray	160 Units of human insulin as nasal spray
Placebo nasal spray	Placebo	Nasalspray containing placebo solution

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity as measured by clamp	45 minutes to 120 minutes post nasal spray	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

Name	Time	Method
Autonomous nervous system activity	45 to 120 minutes post spray	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.

Trial Locations

Locations (1)

University of Tuebingen, Internal medicine IV; 🇩🇪 Tuebingen, Germany