NCT00940134

Brief Summary

The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable obesity

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

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
10 months 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

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

10 months

First QC Date

July 14, 2009

Last Update Submit

June 14, 2012

Conditions

Obesity

Keywords

obesityenergy expenditureincretinsappetite regulationGLP-1PYYad libitum energy intake

Outcome Measures

Primary Outcomes (1)

  • Ad libitum energy intake

    Immediately following 3h IV infusion

Secondary Outcomes (4)

  • Energy expenditure (ventilated hood technique).

    During 3h IV infusion

  • Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin

    Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion

  • Appetite sensation by visual analog scale

    Every 30 minutes during 3h IV infusion

  • Gastric emptying (paracetamol)

    At time=15, 30, 60, 90, 120, 180 mins during IV infusion

Study Arms (4)

placebo

PLACEBO COMPARATOR

Study participants will receive a 3 hour IV infusion of saline while fasting.

Biological: saline infusion

PYY3-36 + GLP-1

EXPERIMENTAL

Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.

Biological: PYY 3-36Biological: GLP-1

GLP-1

ACTIVE COMPARATOR

Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

Biological: GLP-1

PYY3-36

ACTIVE COMPARATOR

Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

Biological: PYY 3-36

Interventions

PYY 3-36BIOLOGICAL

0.8 pmol/kg/min x 3 hours

PYY3-36PYY3-36 + GLP-1
GLP-1BIOLOGICAL

1.0 pmol/kg/min x 3 hours

GLP-1PYY3-36 + GLP-1
saline infusionBIOLOGICAL

saline infusion x 3 hours

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men age 18-50 years
  • BMI ≥30
  • healthy

You may not qualify if:

  • Diabetes mellitus
  • psychological illness
  • on special diets (eg vegetarian, Atkins)
  • weight change of \>3kg within the 2 months prior to screening
  • Hypothalamic or genetic aetiology of obesity
  • diagnosed cancer
  • chronic illness or disease
  • Eating disorder (anorexia or bulimia)
  • smoking
  • substance abuse
  • Use of any prescription or over the counter medication that can affect metabolism
  • Excessive intake of alcohol (\>7 drinks/week)
  • Excessive intake of caffeine (\>300 mg/day)
  • High level of physical activity (\>10 hours/week)
  • Lack of desire or willingness to take part in and follow study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Copenhagen, 1958, Denmark

Location

Related Publications (1)

  • Schmidt JB, Gregersen NT, Pedersen SD, Arentoft JL, Ritz C, Schwartz TW, Holst JJ, Astrup A, Sjodin A. Effects of PYY3-36 and GLP-1 on energy intake, energy expenditure, and appetite in overweight men. Am J Physiol Endocrinol Metab. 2014 Jun 1;306(11):E1248-56. doi: 10.1152/ajpendo.00569.2013. Epub 2014 Apr 15.

    PMID: 24735885DERIVED

MeSH Terms

Conditions

Obesity

Interventions

peptide YY (3-36)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

  • Nikolaj T Gregersen, MSc

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

DK(1)