RecruitingNot ApplicableNCT06912048

Understanding Individual Variability in Neuronal Signal Transmission to Target Organs in Health and Disease


Sponsor

University of Ulm

Enrollment

52 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the influence of parasympathetic transmission from the brain to different metabolic organs. This transmission can be blocked with the muscarinic antagonist atropine. Participants will undergo an oral glucose tolerance test combined with a double tracer dilution technique either with atropine infusion or placebo. Healthy individuals and high-risk individuals will be compared to identify possible changes in signaling in high-risk groups. In addition, men and women will be included to take into account possible sex differences.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria17

  • 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

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Interventions

OTHEROral glucose tolerance test with double-tracer dilution and atropine infusion

Subjects will undergo a 75 g oGTT (180 min) combined with a double tracer dilution. The double-tracer dilution technique will be used to quantify endogenous glucose production, glucose appearance and disappearance rate. \[6,6-2H\]glucose will be infused for a total of 300 minutes, while the infusion will start 120 minutes prior the oGTT and will last until the end of the oGTT. Atropine infusion will be administered 20 minutes before the start of the oGTT. The drink consumed at time point 0 min contains 75 gram glucose, enriched with \[U-13C6\]-glucose.

OTHEROral glucose tolerance test with double-tracer dilution and saline infusion (placebo)

Subjects will undergo a 75 g oGTT (180 min) combined with a double tracer dilution. The double-tracer dilution technique will be used to quantify endogenous glucose production, glucose appearance and disappearance rate. \[6,6-2H\]glucose will be infused for a total of 300 minutes, while the infusion will start 120 minutes prior the oGTT and will last until the end of the oGTT. Saline infusion will be administered 20 minutes before the start of the oGTT. The drink consumed at time point 0 min contains 75 gram glucose, enriched with \[U-13C6\]-glucose.


Locations(1)

Ulm University Hospital

Ulm, Germany

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NCT06912048


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