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

Primary Purpose

Metabolic Syndrome, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intravenous glucagon
Intravenous saline
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Current

    1. febrile infection with temperatures> 38.5 ° C in the last 14 days
    2. Blood donation within the last 12 weeks Pre-study Inclusion

  • Chronic diseases:

    1. Diabetes mellitus
    2. Known liver diseases (hepatitisB/C, hemochromatosis, NASH)
    3. Chronic inflammatory diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) chronic renal insufficiency
    4. Cancer (known malignant disease)
    5. psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia)

    6. 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
    7. Persons with impaired sensitivity and / or increased sensitivity to heating of the body
    8. Medical history of venous thromboembolism
    9. alcohol consumption of more than 50g / day

    10. In physical examination:

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

    11. 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

Sites / Locations

  • University Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intravenous glucagon

Intravenous saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Brain activity
Resting-state brain activity assessed by fMRI

Secondary Outcome Measures

Hunger rating
On visual analogue scale
Brain response to food cues
Assessed by functional magnetic resonance imaging (fMRI)
Glucose tolerance
Assessed by 75 g oral glucose tolerance test
Insulin sensitivity
Assessed during 75 g oral glucose tolerance test
Basal energy expenditure
Assessed by indirect calorimetry
Change in hormone levels
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.

Full Information

First Posted
February 9, 2017
Last Updated
May 4, 2020
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03061227
Brief Title
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge
Official Title
Metabolic and Central Nervous System Characterisation of the Phenotype of Non-suppressed (Rising) Glucagon After Glucose Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous glucagon
Arm Type
Active Comparator
Arm Description
Low-dose glucagon infusion (0.5 pmol/min/kg body weight) over 150 minutes during a standardized 75 g oral glucose tolerance test
Arm Title
Intravenous saline
Arm Type
Placebo Comparator
Arm Description
Saline infusion over 150 minutes during a standardized 75 g oral glucose tolerance test
Intervention Type
Drug
Intervention Name(s)
Intravenous glucagon
Intervention Description
Randomized application of glucagon or saline during oral glucose tolerance test
Intervention Type
Drug
Intervention Name(s)
Intravenous saline
Intervention Description
Randomized application of glucagon or saline during oral glucose tolerance test
Primary Outcome Measure Information:
Title
Brain activity
Description
Resting-state brain activity assessed by fMRI
Time Frame
change from baseline to 120 minutes after oral glucose challenge
Secondary Outcome Measure Information:
Title
Hunger rating
Description
On visual analogue scale
Time Frame
before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion
Title
Brain response to food cues
Description
Assessed by functional magnetic resonance imaging (fMRI)
Time Frame
before, 30 minutes and 120 minutes after oral glucose challenge and start of glucagon/saline infusion
Title
Glucose tolerance
Description
Assessed by 75 g oral glucose tolerance test
Time Frame
0-120 minutes
Title
Insulin sensitivity
Description
Assessed during 75 g oral glucose tolerance test
Time Frame
0-120 minutes
Title
Basal energy expenditure
Description
Assessed by indirect calorimetry
Time Frame
150 minutes after oral glucose challenge
Title
Change in hormone levels
Description
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.
Time Frame
0-150 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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