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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Biological: PYY 3-36
* Biological: GLP-1
* Biological: saline infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Study participants will receive a 3 hour IV infusion of saline while fasting. | Biological: saline infusion<br>* saline infusion x 3 hours<br>|
| Experimental: PYY3-36 + GLP-1<br>Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting. | Biological: PYY 3-36<br>* 0.8 pmol/kg/min x 3 hours<br>Biological: GLP-1<br>* 1.0 pmol/kg/min x 3 hours<br>|
| Active Comparator: GLP-1<br>Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. | Biological: GLP-1<br>* 1.0 pmol/kg/min x 3 hours<br>|
| Active Comparator: PYY3-36<br>Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. | Biological: PYY 3-36<br>* 0.8 pmol/kg/min x 3 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum energy intake |  | Immediately following 3h IV infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PYY, obesity, energy expenditure, incretins, appetite regulation, GLP-1, ad libitum energy intake