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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on October 01, 2014