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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940134

Acronym

INGEAR-1

Enrollment

Registered

2009-07-15

Start date

2011-03-31

Completion date

2012-01-31

Last updated

2012-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, energy expenditure, incretins, appetite regulation, GLP-1, PYY, ad libitum energy intake

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.

Interventions

BIOLOGICALPYY 3-36

0.8 pmol/kg/min x 3 hours

BIOLOGICALGLP-1

1.0 pmol/kg/min x 3 hours

BIOLOGICALsaline infusion

saline infusion x 3 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Ad libitum energy intake	Immediately following 3h IV infusion

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026