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Clinical Trials/NCT03061227
NCT03061227
Completed
Not Applicable

Metabolic and Central Nervous System Characterisation of the Phenotype of Non-suppressed (Rising) Glucagon After Glucose Challenge

University Hospital Tuebingen1 site in 1 country32 target enrollmentFebruary 10, 2017

Overview

Phase
Not Applicable
Intervention
Intravenous glucagon
Conditions
Metabolic Syndrome
Sponsor
University Hospital Tuebingen
Enrollment
32
Locations
1
Primary Endpoint
Brain activity
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. The aims of this study are to i. detect functional differences in the appetite-related central nervous system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.

Registry
clinicaltrials.gov
Start Date
February 10, 2017
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • BMI 18.5- 29.9 kg/m2
  • written informed consent

Exclusion Criteria

  • febrile infection with temperatures\> 38.5 ° C in the last 14 days
  • Blood donation within the last 12 weeks Pre-study Inclusion
  • Chronic diseases:
  • Diabetes mellitus
  • Known liver diseases (hepatitisB/C, hemochromatosis, NASH)
  • Chronic inflammatory diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) chronic renal insufficiency
  • Cancer (known malignant disease)
  • psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia)
  • Persons with non-removable metal parts, e.g:
  • pacemaker

Arms & Interventions

Intravenous glucagon

Low-dose glucagon infusion (0.5 pmol/min/kg body weight) over 150 minutes during a standardized 75 g oral glucose tolerance test

Intervention: Intravenous glucagon

Intravenous saline

Saline infusion over 150 minutes during a standardized 75 g oral glucose tolerance test

Intervention: Intravenous saline

Outcomes

Primary Outcomes

Brain activity

Time Frame: change from baseline to 120 minutes after oral glucose challenge

Resting-state brain activity assessed by fMRI

Secondary Outcomes

  • Basal energy expenditure(150 minutes after oral glucose challenge)
  • Hunger rating(before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion)
  • Glucose tolerance(0-120 minutes)
  • Insulin sensitivity(0-120 minutes)
  • Change in hormone levels(0-150 minutes)
  • Brain response to food cues(before, 30 minutes and 120 minutes after oral glucose challenge and start of glucagon/saline infusion)

Study Sites (1)

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