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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571609
First Posted: April 5, 2012
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Hyperlipidemia Diabetes Mellitus Metabolic Syndrome Arterial Hypertension Obesity Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders

Resource links provided by NLM:


Further study details as provided by Julie Støy, University of Aarhus:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: 10 minutes ]
    Estimation of first phase insulin secretion


Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 240 minutes ]
    Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers

  • body composition [ Time Frame: 60 minutes ]
    Evaluation of body composition using Dxa scan and MRI scan

  • atherosclerosis [ Time Frame: 30 minutes ]
    Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery

  • biochemical blood profiling [ Time Frame: at baseline ]
    Various tests run on blood samples

  • Insulin resistance [ Time Frame: 60 minutes ]
    Biopsi from muscle and adipose tissue performed at baseline and during clamp study.

  • Blood pressure [ Time Frame: 24 hours ]
    Measurement of blood pressure every 20. minutes/24 hours

  • Indirect calorimetry [ Time Frame: 60 minutes ]
    Estimation of resting energy expenditure and respiratory quotient


Enrollment: 40
Study Start Date: August 2012
Study Completion Date: November 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carriers 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: Non-carriers 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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes mellitus
  • Severe illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571609


Locations
Denmark
Medicinsk forskningslaboratorium, Aarhus Universitet
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Lundbeck Foundation
Aarhus University Hospital
Vejle Hospital
Sydvestjysk Hospital
Steno Diabetes Center
University of Copenhagen
Investigators
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie Støy, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01571609     History of Changes
Other Study ID Numbers: 1-10-72-113-12
First Submitted: April 3, 2012
First Posted: April 5, 2012
Last Update Posted: December 2, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders