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NCT Number: NCT03061227

Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge

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.

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Key information

Conditions

Metabolic Syndrome Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Current
  • 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
  • artificial heart valves
  • metal prostheses
  • implanted magnetic metal parts (screws, plates of operations)
  • spiral
  • metal slivers / garnet splinters
  • fixed braces
  • Acupuncture needle
  • Insulin pump
  • totally implantable venous access device (port)
  • tattoos, metallic eye shadows
  • Persons with impaired sensitivity and / or increased sensitivity to heating of the body
  • Medical history of venous thromboembolism
  • alcohol consumption of more than 50g / day
  • In physical examination:

blood pressure > 160/100 mmHg pathologic cardiac murmurs (diastolic or systolic louder than 2/6)

  • in the blood test: fasting glucose ≥ 125 mg/dl or HbA1c ≥ 6.5% AST or ALT> 2.5x upper limit of the reference range (> 125 U/l) Hb <12 g/dl C reactive protein (CRP) > 5 mg / dL or leukocytes> 15000/μl

Treatment and study plan

Intravenous glucagon

Drug

Randomized application of glucagon or saline during oral glucose tolerance test

Intravenous saline

Drug

Randomized application of glucagon or saline during oral glucose tolerance test

Primary outcomes

  1. Brain activity

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

    Resting-state brain activity assessed by fMRI

Secondary outcomes

  1. Hunger rating

    Time frame: before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion

    On visual analogue scale

  2. Brain response to food cues

    Time frame: before, 30 minutes and 120 minutes after oral glucose challenge and start of glucagon/saline infusion

    Assessed by functional magnetic resonance imaging (fMRI)

  3. Glucose tolerance

    Time frame: 0-120 minutes

    Assessed by 75 g oral glucose tolerance test

  4. Insulin sensitivity

    Time frame: 0-120 minutes

    Assessed during 75 g oral glucose tolerance test

  5. Basal energy expenditure

    Time frame: 150 minutes after oral glucose challenge

    Assessed by indirect calorimetry

  6. Change in hormone levels

    Time frame: 0-150 minutes

    Change in adrenocorticotropic hormone (ACTH), growth hormone (GH), thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone (FSH), fibroblast growth factor 21(FGF-21) after oral glucose challenge and start of glucagon/saline infusion.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 23, 2017
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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