Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06487832

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Led by University Hospital Tuebingen · Updated on 2025-03-30

60

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
  • BMI less than 18.5 or greater than 40 kg/m2
  • Persons who cannot legally give consent
  • Pregnancy or lactation
  • History of severe mental or somatic disorders including neurological diseases (including 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 such 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
  • Persons with claustrophobia
  • Persons with tinnitus
  • Weight loss or gain of more than 5% in the last 3 months
  • Pancreatic diseases
  • History or family history of multiple endocrine neoplasia (MEN2) or medullary thyroid cancer
  • History of malignant thyroid disease
  • History of malignant disease in the past 5 years
  • Surgery in the last three months
  • Chronic tobacco use of more than 10 cigarettes/day
  • Women who do not consent to refrain from breastfeeding until 2 months after the end of the study
  • Women of childbearing age who do not consent to use safe method of contraception from 28 days before until 2 months after the end of the study or refrain from heterosexual intercourse during this time
  • Women of childbearing age who do not consent to take a pregnancy test

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Clinic Tubingen, Department of Internal Medicine IV

Tübingen, Germany, 72076

Actively Recruiting

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Research Team

S

Stephanie Kullmann, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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