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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Biological: saline infusion; Biological: PYY 3-36; Biological: GLP-1

• Registration Number: NCT00940134
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2011-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	saline infusion	Study participants will receive a 3 hour IV infusion of saline while fasting.
PYY3-36 + GLP-1	PYY 3-36	Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.
PYY3-36 + GLP-1	GLP-1	Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.
GLP-1	GLP-1	Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.
PYY3-36	PYY 3-36	Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

Primary Outcome Measures

Name	Time	Method
Ad libitum energy intake	Immediately following 3h IV infusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen; 🇩🇰 Copenhagen, Denmark