Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

N/ACompletedNCT01847456

University Hospital Tuebingen10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Insulin Sensitivity

Interventions

human insulin as nasal sprayDRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Tuebingen, Internal medicine IV

Tübingen, Germany

Outcomes

Primary Outcomes

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.

Time frame: 45 minutes to 120 minutes post nasal spray

Secondary Outcomes

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.

Time frame: 45 to 120 minutes post spray

Data from ClinicalTrials.gov

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