NCT03526445

Brief Summary

The objective of the study is to investigate how exogenously administered glucagon affects hepatic lipid, glucose and protein metabolism as well as appetite, food intake and resting energy expenditure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

August 6, 2019

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

May 3, 2018

Last Update Submit

August 5, 2019

Conditions

Non-Alcoholic Fatty Liver DiseaseTotal PancreatectomyDiabetes Mellitus

Keywords

GlucagonStable isotopeEnergy expenditureLipid metabolismGlucose metabolismAppetite

Outcome Measures

Primary Outcomes (1)

  • Hepatic lipid metabolism

    evaluated using isotopic labelled tracer kinetics: lipolysis, ketogenesis, very low-density lipoprotein (VLDL) secretion and free fatty acid (FFA) re-esterification rate

    -120,-30,-15,0,30,60,90,120,135,150 minutes

Secondary Outcomes (7)

  • Changes in plasma concentration of lipids

    0, 60,150 minutes

  • Changes in plasma concentration of amino acids

    0, 60, 120, 150 minutes

  • Changes in plasma concentration of fibroblast growth factor 21 (FGF-21)

    -120,0,150 minutes

  • Endogenous glucose production

    -120,-30,-15,0,30,60,90,120,135,150 minutes

  • Changes in resting energy expenditure and oxidation rate

    0, 150 minutes

  • +2 more secondary outcomes

Study Arms (2)

Glucagon

ACTIVE COMPARATOR

3 hours i.v. infusion of Glucagon (4 ng/kg/min).

Drug: Glucagon

Saline

PLACEBO COMPARATOR

3 hours i.v. infusion of saline

Drug: Saline

Interventions

GlucagonDRUG

Glucagon (4 ng/kg/min)

Also known as: GlucaGen
Glucagon
SalineDRUG

Placebo

Saline

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatectomised patients
  • Patients who have undergone total pancreatectomy
  • Caucasian between 30-80
  • Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females
  • Informed consent
  • Patients with type 1 diabetes
  • Patients with C-peptide negative type 1 diabetes
  • Caucasian between 30-80
  • Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females
  • Informed consent
  • Healthy controls
  • Normal fasting plasma glucose (\< 7 mmol/l) and normal HbA1c (\< 6.5 %) (30,31)
  • Normal blood haemoglobin (\>8.3 mmol/l for males and \>7.3 mmol/l for females)
  • Caucasian between 30-80
  • Informed consent

You may not qualify if:

  • All subjects
  • Inflammatory bowel disease
  • Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy
  • Nephropathy (eGFR \< 60 ml/min/1.73 m² and/or urine albumin \> 20 mg/L)
  • Known liver disease (excluding non-alcoholic fatty liver disease)
  • Severe lung disease
  • Pregnancy and/or breastfeeding
  • Uncontrolled hypertension and/or significant cardiovascular disease
  • Alcohol consumption above 21 units/week for men and 14 units/week for women
  • Any condition that the investigator feels would interfere with the safety of the trial participation or the safety of the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus

Interventions

GlucagonGlucagon-Like Peptide 1Sodium Chloride

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsGlucagon-Like PeptidesGastrointestinal HormonesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Filip Krag Knop, Prof.

    Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

May 1, 2018

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

August 6, 2019

Record last verified: 2018-05

Locations

DK(1)