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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose

NCT01079624

Physiology Gastroenterology Endocrinology

COMPLETED PHASE1

Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.

NCT04186026

Obesity

UNKNOWN NA

Degradation of the Anorexic Hormone Peptide YY

NCT02493959

Healthy

COMPLETED EARLY_PHASE1

Oral Administration of Peptides; Absorption From Gastrointestinal Tract

NCT00468884

Healthy

COMPLETED PHASE1

Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.

NCT01232244

Incretin Action Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

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

Group Type PLACEBO_COMPARATOR

saline infusion

Intervention Type BIOLOGICAL

saline infusion x 3 hours

PYY3-36 + GLP-1

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

Group Type EXPERIMENTAL

PYY 3-36

Intervention Type BIOLOGICAL

0.8 pmol/kg/min x 3 hours

GLP-1

Intervention Type BIOLOGICAL

1.0 pmol/kg/min x 3 hours

GLP-1

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

Group Type ACTIVE_COMPARATOR

GLP-1

Intervention Type BIOLOGICAL

1.0 pmol/kg/min x 3 hours

PYY3-36

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

Group Type ACTIVE_COMPARATOR

PYY 3-36

Intervention Type BIOLOGICAL

0.8 pmol/kg/min x 3 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PYY 3-36

0.8 pmol/kg/min x 3 hours

Intervention Type BIOLOGICAL

GLP-1

1.0 pmol/kg/min x 3 hours

Intervention Type BIOLOGICAL

saline infusion

saline infusion x 3 hours

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes