NCT04372849: Aging

Effects of Age and Obesity on Brain Insulin Sensitivity

Completed NA Last updated 5 November 2020

What this trial tests

NA trial testing Human nasal insulin in Insulin Resistance in 70 participants. Completed in 1 March 2020.

Timeline

28 April 2017

Primary endpoint
1 December 2019

1 March 2020

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	70
Start date	28 April 2017
Primary completion	1 December 2019
Estimated completion	1 March 2020
Sites	1 location across Germany

Drugs / interventions tested

• Human nasal insulin
• Placebo

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Obesity — all drugs for Obesity →

Sponsor

University Hospital Tuebingen

Who can join

Adults 20 to 70, any sex, with Insulin Resistance or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sex differences in central insulin action: Effect of intranasal insulin on neural food cue reactivity in adults with normal weight and overweight.
   Wagner L, Veit R, Fritsche L, Häring HU, et al · · 2022 · cited 22× · PMID 35715625 · DOI 10.1038/s41366-022-01167-3