NCT01900340

Brief Summary

The aim is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

April 3, 2012

Last Update Submit

July 11, 2013

Conditions

Appetite and General Nutritional Disorders

Keywords

GLP-1satiation peptidesfood intake

Outcome Measures

Primary Outcomes (3)

  • Effect of exendin(9-39)on total calorie intake

    60 min test meal

  • Effect of exendin(9-39) on total fluid intake

    60 min test meal

  • Effect of exendin(9-39)on meal duration during an ad libitum test meal.

    60 min test meal

Secondary Outcomes (7)

  • Effect of exendin(9-39)on plasma concentration of glucose

    4 hours blood sampling

  • Effect of exendin(9-39)on plasma concentration of insulin.

    4 hours blood sampling

  • Effect of exendin(9-39)on plasma concentration of glucagon.

    4 hours blood sampling

  • Effect of exendin(9-39)on plasma concentration of GLP-1.

    4 hours blood sampling

  • Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY).

    4 hours blood sampling

  • +2 more secondary outcomes

Study Arms (4)

iv saline, intraduodenal saline

PLACEBO COMPARATOR

intravenous infusion of saline plus intraduodenal administration of saline

Dietary Supplement: Saline

IV exendin(9-39) plus intraduodenal (ID) saline

ACTIVE COMPARATOR

intravenous infusion of exendin(9-39) plus intraduodenal administration of saline

Drug: Exendin 9-39

IV saline, intraduodenal nutrient

PLACEBO COMPARATOR

intravenous infusion of saline plus intraduodenal administration of nutrient

Dietary Supplement: Saline

Exendin(9-39) plus ID nutrient

ACTIVE COMPARATOR

Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration

Drug: Exendin(9-39) plus ID nutrient

Interventions

SalineDIETARY_SUPPLEMENT

Intravenous saline infusion and intraduodenal administration of saline via feeding tube

iv saline, intraduodenal saline
Exendin 9-39DRUG

IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube

IV exendin(9-39) plus intraduodenal (ID) saline
Exendin(9-39) plus ID nutrientDRUG

Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration

Exendin(9-39) plus ID nutrient

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subject with a BMI of 19-25 m2/kg
  • Stable body weight for at least three months
  • Normal eating habits
  • Age between 18 and 45 years
  • Sufficient understanding of the German language
  • Subjects understand the procedures and the risks associated with the study
  • Participants must be willing to adhere to the protocol and sign the consent form

You may not qualify if:

  • Participation in another clinical trial (currently or within the last 30 days)
  • Smoking
  • Substance abuse
  • Regular intake of medications (except for oral contraceptives)
  • Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
  • History of gastrointestinal disorders
  • Food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Phase 1 Research Unit

Basel, Switzerland

Location

Related Publications (1)

  • Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.

    PMID: 24965303DERIVED

MeSH Terms

Interventions

Sodium Chlorideexendin (9-39)

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Christoph Beglinger, MD

    University Hospital Basel, Phase 1 Research Unit, Basel Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

July 16, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

CH(1)