Investigating how brain signals affect organ function in health and disease
Understanding Individual Variability in Neuronal Signal Transmission to Target Organs in Health and Disease
This study tests how blocking brain signals with atropine during a glucose test affects organ function in healthy people and those at risk for metabolic disorders, while also looking at differences between men and women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm Academic / other |
| Locations | 1 site (Ulm) |
| Trial ID | NCT06912048 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the role of parasympathetic transmission from the brain to metabolic organs by using atropine to block this transmission during an oral glucose tolerance test. Participants will undergo a randomized infusion of either atropine or saline placebo before the test, allowing researchers to compare healthy individuals with those at high risk for metabolic disorders. The study also aims to explore sex differences in signaling and metabolic control. A double-tracer dilution technique will be employed to measure glucose production and disappearance rates during the test.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 and older with a BMI between 20-24.9 kg/m2 or overweight individuals with a BMI over 28 kg/m2.
Not a fit: Patients with pre-existing cardiac or neurological conditions, or those on medications affecting blood sugar or the nervous system, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of metabolic regulation and lead to improved treatments for metabolic disorders.
How similar studies have performed: While the specific approach of this study may be novel, similar studies investigating the autonomic nervous system's role in metabolic processes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: at least 18 * BMI: 20 - 24.9 kg/m2 (for the healthy groups) or more than 28 kg/m2 (for the overweight groups) * For women: Hormonal contraception with a single-phase preparation (e.g. Nuvaring) * Understanding and voluntarily signing an informed consent form prior to study-related examinations Exclusion Criteria: * Drug and/or alcohol abuse * smoking * Taking medication that affects blood sugar or addresses the central and/or autonomic nervous system (e.g. anti-epileptic drugs, beta blockers, dopamine agonists, antidepressants). Taking antihistamines. * Pre-existing cardiac conditions * Neurological pre-existing conditions * Known cardiac arrhythmia * Known allergies to ingredients, e.g. paracetamol and atropine * Known narrow-angle glaucoma * Known hyperthyroidism * Known diseases of the urinary tract or prostate * Pregnancy or breastfeeding * At screening: Hb \< 12 g/dl for women and Hb \< 14 g/dl for men * No consent to be informed about incidentally discovered pathological findings * Any (clinical) condition which, in the opinion of the physician, could jeopardize the safety of the * or would jeopardize the scientific success. * Liver dysfunction * Renal insufficiency
Where this trial is running
Ulm
- Ulm University Hospital — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Heni, MD — Ulm University Hopital
- Study coordinator: Martin Heni, MD
- Email: martin.heni@uniklinik-ulm.de
- Phone: +4973150044505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.