NCT04372849

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Last Updated

November 5, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

April 29, 2020

Last Update Submit

November 4, 2020

Conditions

Insulin ResistanceObesity

Outcome Measures

Primary Outcomes (1)

  • Brain insulin sensitivity in different age,weight and sex groups

    fMRI measurement will be performed before and after administration of 160 U of human insulin or placebo as nasal spray. Changes in regional brain activity will be quantified by cerebral blood flow and blood oxygenation dependent (BOLD) signal to assess regional brain insulin sensitivity. Brain insulin sensitivity will be compared between eight groups (young normal weight men and women, young overweight/obese men and women, old normal weight men and women, old overweight/obese men and women). Persons are categorized into normal weight and overweight/obese based on the Body Mass Index (BMI). Age groups are build based on a median split.

    30 minutes after administration of nasal insulin

Secondary Outcomes (4)

  • Whole-body insulin sensitivity

    2 hours

  • Correlation with autonomous nervous system activity

    10 - 150 minutes post nasal spray

  • Correlation with cognitive function

    1 hours

  • Response to food cues

    20 minutes

Study Arms (2)

Nasal insulin spray

ACTIVE COMPARATOR
Other: Human nasal insulin

Placebo spray

PLACEBO COMPARATOR
Other: Placebo

Interventions

Human nasal insulinOTHER

single dose of 160 U of human insulin as nasal spray

Nasal insulin spray
PlaceboOTHER

Single dose of placebo solution as nasal spray

Placebo spray

Eligibility Criteria

Age20 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

April 28, 2017

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

November 5, 2020

Record last verified: 2020-04

Locations

DE(1)