NCT01232244

Brief Summary

Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss. Therefore we want to investigate mechanistic relations between the three hormones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

November 1, 2010

Last Update Submit

December 9, 2013

Conditions

Incretin ActionObesity

Keywords

Incretin hormonesGlucagonSatietyHungerEnergy expenditure

Outcome Measures

Primary Outcomes (4)

  • Gastric emptying

    Assessed by the acetaminophen - method

    4 h

  • Satiety

    Assessed by VAS

    4 h

  • Hunger

    Assessed by an ad'libitum meal

    4 h

  • basal energy expenditure

    Assessed by indirect calorimetry

    2 x 30min

Secondary Outcomes (4)

  • GLP-1

    4 h

  • Oxyntomodulin

    4 h

  • Glucagon

    4 h

  • GIP

    4 h

Study Arms (1)

Healthy young males

Other: GLP-1 infusionOther: Glucagon infusionOther: Oxyntomodulin infusionOther: GLP-1 and glucagon infusionOther: Placebo

Interventions

GLP-1 infusionOTHER

1 pmol/kg/min

Healthy young males
Glucagon infusionOTHER

3ng/kg/min

Healthy young males
Oxyntomodulin infusionOTHER

3 pmol/kg/min

Healthy young males
GLP-1 and glucagon infusionOTHER

1 pmol/kg/min 3 ng/kg/min

Healthy young males
PlaceboOTHER

NaCl 9 g/L infusion

Healthy young males

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy young males

You may qualify if:

  • Normal fasting plasma glucose
  • Normal glucose tolerance
  • Normal haemoglobin levels
  • Informed content

You may not qualify if:

  • Diabetes
  • Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
  • st degree relatives with diabetes
  • Obesity (BMI \> 30)
  • Inflammatory bowels disease
  • Bowels surgery
  • Nephropathy
  • Liver disease
  • Medication which cannot be on hold for 24h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Bagger JI, Holst JJ, Hartmann B, Andersen B, Knop FK, Vilsboll T. Effect of Oxyntomodulin, Glucagon, GLP-1, and Combined Glucagon +GLP-1 Infusion on Food Intake, Appetite, and Resting Energy Expenditure. J Clin Endocrinol Metab. 2015 Dec;100(12):4541-52. doi: 10.1210/jc.2015-2335. Epub 2015 Oct 7.

    PMID: 26445112DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Obesity

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jonatan I Bagger, MD

    Gentofte University Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

DK(1)