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

Summary

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.

Conditions

• Hyperlipidemia
• Diabetes Mellitus
• Metabolic Syndrome
• Arterial Hypertension
• Obesity

Interventions

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.

Sponsors & Collaborators

• Lundbeck Foundation

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Niels Møller, Professor · University of Aarhus

• Oluf B Pedersen, Professor · Steno Diabetes Center Copenhagen

• Torben Hansen, Professor · Steno Diabetes Center Copenhagen

• Jørgen Rungby, Professor · University of Aarhus

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2013-07-31

Completion

2014-11-30

Countries

• Denmark

Study Locations