Postprandial VLDL-TG Metabolism

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
Esben Søndergaard, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01961024
First received: September 27, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Postprandial VLDL-TG Metabolism

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • VLDL-TG storage in adipose tissue [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 18F-THA fractional storage [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

specimen of muscle specimen of adipose tissue


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 diabetic men
Age- and weight-matched controls

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Written consent

Exclusion Criteria:

  • Known diseases
  • Alcohol abuse
  • Smoker
  • Regular use of medicine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961024

Contacts
Contact: Esben Søndergaard, MD, PhD +4578461631 esbens@dadlnet.dk

Locations
Denmark
Department of Endocrinology MEA, Aarhus Hospital Not yet recruiting
Aarhus C, Please Select, Denmark, 8000
Contact    4528730943      
Principal Investigator: Esben Søndergaard, MD, PhD         
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: Esben Søndergaard, Post Doc, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01961024     History of Changes
Other Study ID Numbers: ES-0006
Study First Received: September 27, 2013
Last Updated: October 10, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
VLDL-TG kinetics
Postprandial state
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014