NCT01961024

Brief Summary

In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2 diabetic and healthy subjects matched for BMI in order to elucidate the potential pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes that might be involved in regulating skeletal muscle and adipose tissue FA storage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

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

September 27, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

September 27, 2013

Last Update Submit

May 1, 2017

Conditions

Type 2 Diabetes

Keywords

VLDL-TG kineticsPostprandial stateObesity

Outcome Measures

Primary Outcomes (1)

  • VLDL-TG storage in adipose tissue

    3 hours

Secondary Outcomes (1)

  • 18F-THA fractional storage

    6 Hours

Study Arms (2)

Type 2 diabetic men

Age- and weight-matched controls

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males with diabetes from the department´s out-patient clinic. Control group of healthy volunteers

You may qualify if:

  • Written consent

You may not qualify if:

  • Known diseases
  • Alcohol abuse
  • Smoker
  • Regular use of medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology MEA, Aarhus Hospital

Aarhus C, Please Select, 8000, Denmark

Location

Related Publications (1)

  • Sondergaard E, Johansen RF, Jensen MD, Nielsen S. Postprandial VLDL-TG metabolism in type 2 diabetes. Metabolism. 2017 Oct;75:25-35. doi: 10.1016/j.metabol.2017.07.002. Epub 2017 Jul 19.

    PMID: 28964326DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

specimen of muscle specimen of adipose tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doc, MD, PhD

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 11, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

DK(1)