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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00940134
First received: July 14, 2009
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Biological: PYY 3-36
Biological: GLP-1
Biological: saline infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Ad libitum energy intake [ Time Frame: Immediately following 3h IV infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy expenditure (ventilated hood technique). [ Time Frame: During 3h IV infusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Appetite sensation by visual analog scale [ Time Frame: Every 30 minutes during 3h IV infusion ] [ Designated as safety issue: No ]
  • Gastric emptying (paracetamol) [ Time Frame: At time=15, 30, 60, 90, 120, 180 mins during IV infusion ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940134

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Nikolaj T Gregersen, MSc University of Copenhagen
  More Information

No publications provided

Responsible Party: AAstrup, Professor, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00940134     History of Changes
Other Study ID Numbers: B262
Study First Received: July 14, 2009
Last Updated: June 14, 2012
Health Authority: Denmark: Danish Data Protection Agency
Denmark: Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
obesity
energy expenditure
incretins
appetite regulation
 GLP-1
PYY
ad libitum energy intake

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013