Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

University Hospital Tuebingen

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Drug: Placebo; Drug: Human Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01797601

Eudra-CT: 2006-002244-29

17/2008AMG1 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal routine blood works
• for women: negative pregnancy test
• healthy

Exclusion criteria

• Type 2 diabetes
• pregnancy
• acute or chronic diseases
• Pacemakers
• Artificial heart valves
• Metal prostheses
• Implanted magnetic metal parts (screws, ...)
• Metal fragments
• Braces
• insulin pumps
• Tattoos
• claustrophobia
• reduced temperature sensation and / or increased sensitivity to warming of the body
• Ear disease or an increased sensitivity to loud noises

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 2 patient groups, including a placebo group

Human Insulin

Active Comparator group

Description:

Nasal spray

Treatment:

Drug: Human Insulin

Placebo solution

Placebo Comparator group

Description:

Nasal spray

Treatment:

Drug: Placebo