NCT01178957

Brief Summary

The purpose of this study is to estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

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

April 21, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

April 21, 2010

Last Update Submit

August 5, 2013

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesVery-Low-Density-Lipoprotein(VLDL)Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion

    Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) kinetics over a single study day

    8 hours

Study Arms (1)

Type 1 diabetes

Other: Hyperglycemia

Interventions

HyperglycemiaOTHER

Hyperglycemia with a blood glucose of 15 mmol/L

Type 1 diabetes

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetics

You may qualify if:

  • Type 1 diabetes
  • Age 18-50 years

You may not qualify if:

  • Smoking
  • Alcohol abuse
  • Use of medications (except insulin in diabetics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology MEA, Aarhus Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Johansen RF, Sondergaard E, Sorensen LP, Nellemann B, Christiansen JS, Nielsen S. Isolated hyperglycaemia does not increase VLDL-triacylglycerol secretion in type 1 diabetic men. Diabetologia. 2015 Feb;58(2):355-62. doi: 10.1007/s00125-014-3422-6. Epub 2014 Nov 11.

    PMID: 25385409DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2010

First Posted

August 10, 2010

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

DK(1)