Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

NCT06487832 | Recruiting

• 1 other identifier: 065/2024BO1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.

Conditions

Normal Weight; Overweight and Obesity; Insulin Sensitivity; Insulin Resistance

Keywords

GLP-1; Brain; functional magnetic resonance imaging; Semaglutide

Outcome Measures

Primary Outcomes (1)

• Cerebral response after insulin compared to placebo nasal spray

  Resting-state cerebral blood flow and BOLD-fMRI response from before to 30 min after nasal spray administration

  24 hours after semaglutide or placebo administration

Secondary Outcomes (6)

• Neural food-cue reactivity after insulin compared to placebo nasal spray

  24 hours after semaglutide or placebo administration

• Diffusion-weighted imaging (DWI)

  24 hours after semaglutide or placebo administration

• Heart rate variability (HRV)

  24 hours after semaglutide or placebo administration

• Change in subjective feeling of hunger and food craving

  24 hours after semaglutide or placebo administration

• Change in mood

  24 hours after semaglutide or placebo administration

Study Arms (2)

GLP-1

EXPERIMENTAL

Acute administration of 0.25 mg semaglutide (0.19 ml)

Other: Subcutaneous GLP1-RA

Placebo

PLACEBO COMPARATOR

Acute administration of 0.19 ml NaCl

Other: Subcutaneous placebo

Interventions

Subcutaneous GLP1-RA OTHER

Subcutaneous administration of semaglutide

GLP-1

Subcutaneous placebo OTHER

Subcutaneous administration of NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 18.5 and 24.9 kg/m2; and between 27.5 kg/m2 and 40 kg/m2
• Written consent to participate in the study
• Written consent to be informed about incidental findings

You may not qualify if:

• Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
• BMI \< 18.5 or \> 40 kg/m2
• Persons who cannot legally give consent
• Pregnancy or lactation
• History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures)
• Taking psychotropic drugs
• Chronic diseases or medication that influence glucose metabolism
• Regular use of analgesic drugs
• Previous bariatric surgery
• Known allergy against one or more of the used agents
• Acute infection and/or antibiotic treatment within the last 4 weeks
• Hemoglobin values less than 10.5 g/dl for women, less than 11.5 g/dl for men
• Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
• Participation in a lifestyle intervention study or a pharmaceutical study within the last 30 days
• Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Clinic Tubingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Andreas L. Birkenfeld, MD

  Institute for Diabetes research and Metabolic Diseases at the University of Tubingen

  STUDY DIRECTOR

Central Study Contacts

Stephanie Kullmann, PhD

CONTACT

0049707129; stephanie.kullmann@med.uni-tuebingen.de

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: SPONSOR

Model Details: In a randomized, single-blinded, within subject cross-over design, we will compare cerebral response from before to after intranasal insulin or placebo administration after a single dose of 0.25 mg semaglutide administration versus placebo administration

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)