- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01232244
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
December 9, 2013 updated by: Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.
Therefore we want to investigate mechanistic relations between the three hormones.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hellerup, Denmark, 2900
- Gentofte University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Healthy young males
Description
Inclusion Criteria:
- Normal fasting plasma glucose
- Normal glucose tolerance
- Normal haemoglobin levels
- Informed content
Exclusion Criteria:
- Diabetes
- Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
- 1st degree relatives with diabetes
- Obesity (BMI > 30)
- Inflammatory bowels disease
- Bowels surgery
- Nephropathy
- Liver disease
- Medication which cannot be on hold for 24h
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy young males
|
1 pmol/kg/min
3ng/kg/min
3 pmol/kg/min
1 pmol/kg/min 3 ng/kg/min
NaCl 9 g/L infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying
Time Frame: 4 h
|
Assessed by the acetaminophen - method
|
4 h
|
Satiety
Time Frame: 4 h
|
Assessed by VAS
|
4 h
|
Hunger
Time Frame: 4 h
|
Assessed by an ad'libitum meal
|
4 h
|
basal energy expenditure
Time Frame: 2 x 30min
|
Assessed by indirect calorimetry
|
2 x 30min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GLP-1
Time Frame: 4 h
|
4 h
|
Oxyntomodulin
Time Frame: 4 h
|
4 h
|
Glucagon
Time Frame: 4 h
|
4 h
|
GIP
Time Frame: 4 h
|
4 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonatan I Bagger, MD, Gentofte University Hospital, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (Estimate)
November 2, 2010
Study Record Updates
Last Update Posted (Estimate)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 9, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXMDissek
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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