Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
andreas fritsche, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01847456
First received: April 28, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Insulin Sensitivity
Drug: human insulin as nasal spray
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Insulin sensitivity as measured by clamp [ Time Frame: 45 minutes to 120 minutes post nasal spray ] [ Designated as safety issue: No ]
    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 [ Time Frame: 45 to 120 minutes post spray ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: April 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin nasal spray
160 Units of human insulin as nasal spray
Drug: human insulin as nasal spray
Placebo Comparator: Placebo nasal spray
Nasalspray containing placebo solution
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847456

Locations
Germany
University of Tuebingen, Internal medicine IV
Tuebingen, Germany, 72074
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: andreas fritsche, Professor of Medicine, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01847456     History of Changes
Other Study ID Numbers: SFB 997 A01 WP7
Study First Received: April 28, 2013
Last Updated: December 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
whole body insulin sensitivity
insulin action in the brain

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014