NCT01779622

Brief Summary

To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

January 27, 2013

Last Update Submit

September 29, 2014

Conditions

Healthy Volunteers Recruited From the General Population

Keywords

mixed meal¨insulinglucagonGIPGLP-1

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for insulin

    300 min

Secondary Outcomes (2)

  • Area under the curve for glucose-dependent insuinotropic polypeptide

    300 min

  • Area under the curve for glucagon-like peptide-1

    300 min

Other Outcomes (1)

  • Area under the curve for glucagon

    300 min

Study Arms (1)

1

EXPERIMENTAL

Healthy volunteers are ingesting a mixed meal either rapidly or slowly

Other: Mixed meal

Interventions

Mixed mealOTHER

Ingestion of mixed meal

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Diabetes Liver disease Kidney disease Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Sciences, Lund University

Lund, 22184, Sweden

Location

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2013

First Posted

January 30, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

SE(1)