Clinical trial NCT00940134: Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
energy expenditure
incretins
appetite regulation
GLP-1
PYY
ad libitum energy intake
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Ad libitum energy intake
timeFrame: Immediately following 3h IV infusion
Secondary outcomes:
measure: Energy expenditure (ventilated hood technique).
timeFrame: During 3h IV infusion
measure: Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin
timeFrame: Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion
measure: Appetite sensation by visual analog scale
timeFrame: Every 30 minutes during 3h IV infusion
measure: Gastric emptying (paracetamol)
timeFrame: At time=15, 30, 60, 90, 120, 180 mins during IV infusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Nikolaj T Gregersen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.