Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers

This study is not yet open for participant recruitment.

Verified January 2013 by Lund University

Sponsor:

Information provided by (Responsible Party):

Bo Ahren, Lund University

ClinicalTrials.gov Identifier:

NCT01779622

First received: January 27, 2013

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 27, 2013
Last Updated Date	January 29, 2013
Start Date ^ICMJE	March 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 29, 2013)	Area under the curve for insulin [ Time Frame: 300 min ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01779622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 29, 2013)	Area under the curve for glucose-dependent insuinotropic polypeptide [ Time Frame: 300 min ] [ Designated as safety issue: No ] Area under the curve for glucagon-like peptide-1 [ Time Frame: 300 min ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: January 29, 2013)	Area under the curve for glucagon [ Time Frame: 300 min ] [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers
Official Title ^ICMJE	Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin
Brief Summary	To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers Recruited From the General Population
Intervention ^ICMJE	Other: Mixed meal Ingestion of mixed meal
Study Arm (s)	Experimental: 1 Healthy volunteers are ingesting a mixed meal either rapidly or slowly Intervention: Other: Mixed meal
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	24
Estimated Completion Date	June 2014
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes Liver disease Kidney disease Thyroid disease
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01779622
Other Study ID Numbers ^ICMJE	17, 2013-000449-38
Has Data Monitoring Committee	Yes
Responsible Party	Bo Ahren, Lund University
Study Sponsor ^ICMJE	Lund University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Lund University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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