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OpenTrials
Completed

NCT Number: NCT01847456

Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

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

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Key information

Conditions

Insulin Sensitivity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Internal medicine IV

Tübingen, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human insulin as nasal spray

Drug

Placebo

Drug

Primary outcomes

  1. Insulin sensitivity as measured by clamp

    Time frame: 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 outcomes

  1. Autonomous nervous system activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
May 6, 2013
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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