Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabo... | NCT01178957

Studies
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia

NCT01178957

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Aug 7, 2013Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Type 1 Diabetes

Interventions

Hyperglycemia

Countries

Denmark

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

Status Module

Record Verification Date

Aug 2013

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

Apr 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Apr 21, 2010

First Submission Date that Met QC Criteria

Aug 9, 2010

First Posted Date

Aug 10, 2010Estimated

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

Aug 5, 2013

Last Update Posted Date

Aug 7, 2013Estimated

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 1 diabetes			Other: Hyperglycemia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperglycemia	Other	Hyperglycemia with a blood glucose of 15 mmol/L	Type 1 diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion	Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) kinetics over a single study day	8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes
Age 18-50 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Type 1 diabetics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology MEA, Aarhus Hospital		Aarhus C		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25385409	Derived	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.

ID	Term
D003922	Diabetes Mellitus, Type 1
D006943	Hyperglycemia

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases