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Completed

NCT Number: NCT00940134

Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PYY 3-36

Biological

0.8 pmol/kg/min x 3 hours

GLP-1

Biological

1.0 pmol/kg/min x 3 hours

saline infusion

Biological

saline infusion x 3 hours

Primary outcomes

  1. Ad libitum energy intake

    Time frame: Immediately following 3h IV infusion

Secondary outcomes

  1. Energy expenditure (ventilated hood technique).

    Time frame: During 3h IV infusion

  2. 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

  3. Appetite sensation by visual analog scale

    Time frame: Every 30 minutes during 3h IV infusion

  4. Gastric emptying (paracetamol)

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study 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.

Acronym: INGEAR-1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2009
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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