Effect of Weight Loss on Brain Insulin Sensitivity in Humans

Insulin Resistance Clinical Trial

Official title:

Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02991365
• Other study ID #: 8 weeks study
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: Andreas Fritsche, MD
• Phone: +49 7071 29 80687
• Email: andreas.fritsche[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• nasal insulin

• placebo spray

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain insulin sensitivity	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.	30 minutes after administration of nasal insulin
Secondary	Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.	Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body weight will be recorded.	8 weeks
Secondary	Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .	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.	8 weeks
Secondary	Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .	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.	8 weeks
Secondary	whole-body insulin sensitivity	Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.	2 hours
Secondary	Glucose tolerance	a 75 g oral glucose tolerance test will be performed. Glucose tolerance will be defined by the American Diabetes Association criteria.	2 hours
Secondary	Cognitive function	cognitive function will be addressed by neuropsychological testing.	1 hours