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OpenTrials
Completed

NCT Number: NCT01571609

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.

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Key information

Conditions

Hyperlipidemia Arterial Hypertension Body Weight Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medicinsk forskningslaboratorium, Aarhus Universitet

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diabetes mellitus
  • Severe illness

Treatment and study plan

first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer

Other

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.

Primary outcomes

  1. insulin secretion

    Time frame: 10 minutes

    Estimation of first phase insulin secretion

Secondary outcomes

  1. Insulin resistance

    Time frame: 240 minutes

    Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers

  2. body composition

    Time frame: 60 minutes

    Evaluation of body composition using Dxa scan and MRI scan

  3. atherosclerosis

    Time frame: 30 minutes

    Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery

  4. biochemical blood profiling

    Time frame: at baseline

    Various tests run on blood samples

  5. Insulin resistance

    Time frame: 60 minutes

    Biopsi from muscle and adipose tissue performed at baseline and during clamp study.

  6. Blood pressure

    Time frame: 24 hours

    Measurement of blood pressure every 20. minutes/24 hours

  7. Indirect calorimetry

    Time frame: 60 minutes

    Estimation of resting energy expenditure and respiratory quotient

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Lundbeck Foundation
  • Steno Diabetes Center Copenhagen
  • University of Copenhagen
  • Vejle Hospital

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 5, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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