Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism. (INGEAR-1)

University of Copenhagen

Status: Completed

Conditions: Obesity

Treatments: Biological: saline infusion; Biological: GLP-1; Biological: PYY 3-36

Study type: Interventional

Funder types: Other

Identifiers

NCT00940134

B262

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Study participants will receive a 3 hour IV infusion of saline while fasting.

Treatment:

Biological: saline infusion

PYY3-36 + GLP-1

Experimental group

Description:

Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.

Treatment:

Biological: PYY 3-36

Biological: GLP-1

GLP-1

Active Comparator group

Description:

Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

Treatment:

Biological: GLP-1

PYY3-36

Active Comparator group

Description:

Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.

Treatment:

Biological: PYY 3-36