Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism. (INGEAR-1)

June 14, 2012 updated by: AAstrup, University of Copenhagen

INGEAR-1: Effects of INtravenous Infusions of PYY3-36 and GLP-1, as Monoinfusion and in Combination, on ad Libitum Energy Intake, Appetite Sensation, and Energy Expenditure in Healthy Obese Subjects.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1958
        • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Study participants will receive a 3 hour IV infusion of saline while fasting.
Biological: saline infusion
saline infusion x 3 hours
Experimental: PYY3-36 + GLP-1
Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.
Biological: PYY 3-36
0.8 pmol/kg/min x 3 hours
Biological: GLP-1
1.0 pmol/kg/min x 3 hours
Active Comparator: GLP-1
Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.
Biological: GLP-1
1.0 pmol/kg/min x 3 hours
Active Comparator: PYY3-36
Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.
Biological: PYY 3-36
0.8 pmol/kg/min x 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ad libitum energy intake
Time Frame: Immediately following 3h IV infusion
Immediately following 3h IV infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Energy expenditure (ventilated hood technique).
Time Frame: During 3h IV infusion
During 3h IV infusion
Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin
Time Frame: Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion
Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion
Appetite sensation by visual analog scale
Time Frame: Every 30 minutes during 3h IV infusion
Every 30 minutes during 3h IV infusion
Gastric emptying (paracetamol)
Time Frame: At time=15, 30, 60, 90, 120, 180 mins during IV infusion
At time=15, 30, 60, 90, 120, 180 mins during IV infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Nikolaj T Gregersen, MSc, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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