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

University of Copenhagen24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

PYY 3-36BIOLOGICAL

0.8 pmol/kg/min x 3 hours

GLP-1BIOLOGICAL

1.0 pmol/kg/min x 3 hours

saline infusionBIOLOGICAL

saline infusion x 3 hours

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Copenhagen, Denmark

Outcomes

Primary Outcomes

Ad libitum energy intake

Time frame: Immediately following 3h IV infusion

Secondary Outcomes

Energy expenditure (ventilated hood technique).

Time frame: During 3h IV infusion

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

Appetite sensation by visual analog scale

Time frame: Every 30 minutes during 3h IV infusion

Gastric emptying (paracetamol)

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

Data from ClinicalTrials.gov

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