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

Obesity Clinical Trial

— INGEAR-1  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940134
• Other study ID #: B262
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: June 14, 2012
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection AgencyDenmark: Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Biological:
• PYY 3-36
0.8 pmol/kg/min x 3 hours
• GLP-1
1.0 pmol/kg/min x 3 hours
• saline infusion
saline infusion x 3 hours

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum energy intake		Immediately following 3h IV infusion	No
Secondary	Energy expenditure (ventilated hood technique).		During 3h IV infusion	No
Secondary	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	No
Secondary	Appetite sensation by visual analog scale		Every 30 minutes during 3h IV infusion	No
Secondary	Gastric emptying (paracetamol)		At time=15, 30, 60, 90, 120, 180 mins during IV infusion	No