Effect of Weight Loss on Brain Insulin Sensitivity in Humans

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT02991365

Collaborator

(none)

Enrollment

Location

Arms

74.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Other: nasal insulin Other: placebo spray	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: nasal insulin daily administration of 160 U of human insulin as nasal spray	Other: nasal insulin
Placebo Comparator: placebo spray daily administration of placebo solution as nasal spray	Other: placebo spray

Arm

Intervention/Treatment

Active Comparator: nasal insulin

daily administration of 160 U of human insulin as nasal spray

Other: nasal insulin

Placebo Comparator: placebo spray

daily administration of placebo solution as nasal spray

Other: placebo spray

Outcome Measures

Primary Outcome Measures

brain insulin sensitivity [30 minutes after administration of nasal insulin]
fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.

Secondary Outcome Measures

Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight. [8 weeks]
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body weight will be recorded.
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance . [8 weeks]
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks glucose tolerance will be assessed using a 75 g oral glucose tolerance test.
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition . [8 weeks]
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body composition will be addressed by whole-body MRI and liver MRS.
whole-body insulin sensitivity [2 hours]
Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.
Glucose tolerance [2 hours]
a 75 g oral glucose tolerance test will be performed. Glucose tolerance will be defined by the American Diabetes Association criteria.
Cognitive function [1 hours]
cognitive function will be addressed by neuropsychological testing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

HbA1c <6.5%
Age between 40 and 75 years
No intake of antidiabetic drugs or drugs for weight reduction
no steroid intake
Stable medication over 10 weeks before the start of the study

Exclusion Criteria:

Persons who wear non-removable metal parts in or on the body.
Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
Persons with hearing impairment or increased sensitivity to loud noises
People with claustrophobia
Minors or non-consenting subjects are also excluded
Subjects with an operation less than 3 months
Simultaneous participation in other studies
Neurological and psychiatric disorders
Subjects with hemoglobin Hb <11 g / dl
Hypersensitivity to any of the substances used

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tuebingen, Department of Internal Medicine IV	Tübingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator: Andreas Fritsche, MD, University of Tübingen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT02991365

Other Study ID Numbers:

8 weeks study

First Posted:

Dec 13, 2016

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Insulin Resistance

Insulin

Study Results

No Results Posted as of Mar 28, 2022