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Effects of Age and Obesity on Brain Insulin Sensitivity

NCT ID: NCT04372849

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2020-03-01

Brief Summary

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Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.

Detailed Description

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Conditions

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Insulin Resistance Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nasal insulin spray

Group Type ACTIVE_COMPARATOR

Human nasal insulin

Intervention Type OTHER

single dose of 160 U of human insulin as nasal spray

Placebo spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo solution as nasal spray

Interventions

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Human nasal insulin

single dose of 160 U of human insulin as nasal spray

Intervention Type OTHER

Placebo

Single dose of placebo solution as nasal spray

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body-Mass Index (BMI) between 19-35 kg/m2
* HbA1c ≤6.0%
* normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion Criteria

* Not removable metal parts in or on the body
* manifest cardiovascular disease
* claustrophobia
* recent surgery (less than 3 months)
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* neurological and psychiatric disorders
* treatment with centrally acting drugs
* hemoglobin Hb \<13g / dl
* Hypersensitivity to any of the substances used
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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837/2016BO2

Identifier Type: -

Identifier Source: org_study_id