NCT03061227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

February 9, 2017

Last Update Submit

May 4, 2020

Conditions

Metabolic SyndromeDiabetes

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    Resting-state brain activity assessed by fMRI

    change from baseline to 120 minutes after oral glucose challenge

Secondary Outcomes (6)

  • Hunger rating

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

  • Brain response to food cues

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

  • Glucose tolerance

    0-120 minutes

  • Insulin sensitivity

    0-120 minutes

  • Basal energy expenditure

    150 minutes after oral glucose challenge

  • +1 more secondary outcomes

Study Arms (2)

Intravenous glucagon

ACTIVE COMPARATOR

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

Drug: Intravenous glucagon

Intravenous saline

PLACEBO COMPARATOR

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

Drug: Intravenous saline

Interventions

Intravenous glucagonDRUG

Randomized application of glucagon or saline during oral glucose tolerance test

Intravenous glucagon
Intravenous salineDRUG

Randomized application of glucagon or saline during oral glucose tolerance test

Intravenous saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current
  • febrile infection with temperatures\> 38.5 ° C in the last 14 days
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

February 10, 2017

Primary Completion

January 17, 2019

Study Completion

April 30, 2020

Last Updated

May 5, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)