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
  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: 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 University of Aarhus:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Estimation of first phase insulin secretion


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Julie Støy, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01571609     History of Changes
Other Study ID Numbers: 1-10-72-113-12
Study First Received: April 3, 2012
Last Updated: July 10, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hypertension
Metabolic Diseases
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 17, 2014