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Clinical Trials/NCT01571609
NCT01571609CompletedNot Applicable

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

University of Aarhus1 site in 1 country40 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
insulin secretion

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •18-70 years of age
  • •Member of Biobank Vejle

Exclusion Criteria

  • •Diabetes mellitus
  • •Severe illness

Arms & Interventions

Carriers

Experimental

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

Non-carriers

Experimental

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

Outcomes

Primary Outcomes

insulin secretion

Time Frame: 10 minutes

Estimation of first phase insulin secretion

Secondary Outcomes

  • Insulin resistance(60 minutes)
  • body composition(60 minutes)
  • atherosclerosis(30 minutes)
  • biochemical blood profiling(at baseline)
  • Blood pressure(24 hours)
  • Indirect calorimetry(60 minutes)
  • Insulin resistance(240 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Julie Støy

MD

University of Aarhus

Study Sites (1)

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