NCT01797601

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

February 18, 2013

Last Update Submit

December 2, 2015

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • Insulin effect on regional brain activity assessed by fMRI

    Change from Baseline to 15 minutes and 60 minutes post spray application

Study Arms (2)

Human Insulin

ACTIVE COMPARATOR

Nasal spray

Drug: Human Insulin

Placebo solution

PLACEBO COMPARATOR

Nasal spray

Drug: Placebo

Interventions

Human InsulinDRUG

160 U of insulin

Human Insulin
PlaceboDRUG

Insulin dilution medium without insulin

Placebo solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen

Tübingen, 72074, Germany

Location

Related Publications (1)

  • Kullmann S, Heni M, Veit R, Scheffler K, Machann J, Haring HU, Fritsche A, Preissl H. Selective insulin resistance in homeostatic and cognitive control brain areas in overweight and obese adults. Diabetes Care. 2015 Jun;38(6):1044-50. doi: 10.2337/dc14-2319. Epub 2015 Mar 20.

    PMID: 25795413DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andreas Fritsche, MD

    Universität Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Andreas Fritsche

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 22, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

DE(1)