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Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Lundbeck Foundation
Aarhus University Hospital
Vejle Hospital
Sydvestjysk Hospital
Steno Diabetes Center
University of Copenhagen
Information provided by (Responsible Party):
Julie Støy, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01571609
First received: April 3, 2012
Last updated: July 10, 2013
Last verified: July 2013

April 3, 2012
July 10, 2013
August 2012
December 2013   (final data collection date for primary outcome measure)
insulin secretion [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Estimation of first phase insulin secretion
Same as current
Complete list of historical versions of study NCT01571609 on ClinicalTrials.gov Archive Site
  • Insulin resistance [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]
    Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
  • body composition [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Evaluation of body composition using Dxa scan and MRI scan
  • atherosclerosis [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
  • biochemical blood profiling [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Various tests run on blood samples
  • Insulin resistance [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
    Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
  • Blood pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Measurement of blood pressure every 20. minutes/24 hours
  • Indirect calorimetry [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Estimation of resting energy expenditure and respiratory quotient
Same as current
Not Provided
Not Provided
 
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders

The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hyperlipidemia
  • Diabetes Mellitus
  • Metabolic Syndrome
  • Arterial Hypertension
  • Obesity
Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer

FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes.

HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes

Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes.

Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes.

  • Experimental: Carriers
    Intervention: Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
  • Experimental: Non-carriers
    Intervention: Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
February 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • 18-70 years of age
  • Member of Biobank Vejle
  • BMI<30

Exclusion Criteria:

  • Diabetes mellitus
  • Severe illness
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01571609
1-10-72-113-12
Yes
Julie Støy, University of Aarhus
University of Aarhus
  • Lundbeck Foundation
  • Aarhus University Hospital
  • Vejle Hospital
  • Sydvestjysk Hospital
  • Steno Diabetes Center
  • University of Copenhagen
Principal Investigator: Niels Møller, Professor University of Aarhus
Principal Investigator: Oluf B Pedersen, Professor Steno Diabetes Center
Principal Investigator: Torben Hansen, Professor Steno Diabetes Center
Principal Investigator: Jørgen Rungby, Professor University of Aarhus
University of Aarhus
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP