Rapid Versus Slow Ingestion of Mixed Meal: Influence on I... | NCT01779622

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

NCT01779622

Sponsor

Lund University

Status

Completed

Last Update Posted

Sep 30, 2014Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Healthy Volunteers Recruited From the General Population

Interventions

Mixed meal

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000449-38	EudraCT Number

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 27, 2013

First Submission Date that Met QC Criteria

Jan 29, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2014

Last Update Posted Date

Sep 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Healthy volunteers are ingesting a mixed meal either rapidly or slowly	Other: Mixed meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixed meal	Other	Ingestion of mixed meal	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve for insulin		300 min

Secondary Outcomes

Measure	Description	Time Frame
Area under the curve for glucose-dependent insuinotropic polypeptide		300 min
Area under the curve for glucagon-like peptide-1		300 min

Other Outcomes

Measure	Description	Time Frame
Area under the curve for glucagon		300 min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Diabetes Liver disease Kidney disease Thyroid disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Sciences, Lund University		Lund		22184	Sweden

Label	URL
Faculty of Medicine, Lund university	View source

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided