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

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ClinicalTrials.gov Identifier: NCT01779622
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University

Tracking Information
First Submitted Date  ICMJE January 27, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date September 30, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2014   (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 ]
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 ]
  • Area under the curve for glucagon-like peptide-1 [ Time Frame: 300 min ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 29, 2013)
Area under the curve for glucagon [ Time Frame: 300 min ]
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Diabetes Liver disease Kidney disease Thyroid disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779622
Other Study ID Numbers  ICMJE 17
2013-000449-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bo Ahren, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lund University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP