Effect of Weight Loss on Brain Insulin Sensitivity in Humans

NCT02991365 | Recruiting

• 1 other identifier: 8 weeks study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.

  8 weeks

• Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .

  8 weeks

• Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .

  8 weeks

• whole-body insulin sensitivity

  2 hours

• Glucose tolerance

  2 hours

Study Arms (2)

nasal insulin

ACTIVE COMPARATOR

daily administration of 160 U of human insulin as nasal spray

Other: nasal insulin

placebo spray

PLACEBO COMPARATOR

daily administration of placebo solution as nasal spray

Other: placebo spray

Interventions

nasal insulin OTHER

nasal insulin

placebo spray OTHER

placebo spray

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andreas Fritsche, MD

  University of Tübingen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Fritsche, MD

CONTACT

+49 7071 29 80687; andreas.fritsche@med.uni-tuebingen.de

Study Design

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

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)