- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779622
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers
September 29, 2014 updated by: Bo Ahren, Lund University
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin
To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
-
-
-
Lund, Sweden, 22184
- Department of Clinical Sciences, Lund University
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Diabetes Liver disease Kidney disease Thyroid disease
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?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Healthy volunteers are ingesting a mixed meal either rapidly or slowly
|
Ingestion of mixed meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve for insulin
Time Frame: 300 min
|
300 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve for glucose-dependent insuinotropic polypeptide
Time Frame: 300 min
|
300 min
|
Area under the curve for glucagon-like peptide-1
Time Frame: 300 min
|
300 min
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve for glucagon
Time Frame: 300 min
|
300 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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
June 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 27, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 30, 2013
Study Record Updates
Last Update Posted (Estimate)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17
- 2013-000449-38 (EudraCT Number)
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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