NCT01571609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

April 3, 2012

Last Update Submit

December 1, 2014

Conditions

HyperlipidemiaDiabetes MellitusMetabolic SyndromeArterial HypertensionObesity

Outcome Measures

Primary Outcomes (1)

  • insulin secretion

    Estimation of first phase insulin secretion

    10 minutes

Secondary Outcomes (7)

  • Insulin resistance

    240 minutes

  • body composition

    60 minutes

  • atherosclerosis

    30 minutes

  • biochemical blood profiling

    at baseline

  • Insulin resistance

    60 minutes

  • +2 more secondary outcomes

Study Arms (2)

Carriers

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

Non-carriers

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

Interventions

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

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.

CarriersNon-carriers

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • years of age
  • Member of Biobank Vejle
  • BMI\<30

You may not qualify if:

  • Diabetes mellitus
  • Severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicinsk forskningslaboratorium, Aarhus Universitet

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • Stoy J, Kampmann U, Mengel A, Magnusson NE, Jessen N, Grarup N, Rungby J, Stodkilde-Jorgensen H, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N. Reduced CD300LG mRNA tissue expression, increased intramyocellular lipid content and impaired glucose metabolism in healthy male carriers of Arg82Cys in CD300LG: a novel genometabolic cross-link between CD300LG and common metabolic phenotypes. BMJ Open Diabetes Res Care. 2015 Aug 26;3(1):e000095. doi: 10.1136/bmjdrc-2015-000095. eCollection 2015.

    PMID: 26336608DERIVED

  • Stoy J, Grarup N, Horlyck A, Ibsen L, Rungby J, Poulsen PL, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N, Kampmann U. Blood pressure levels in male carriers of Arg82Cys in CD300LG. PLoS One. 2014 Oct 14;9(10):e109646. doi: 10.1371/journal.pone.0109646. eCollection 2014.

    PMID: 25314291DERIVED

Related Links

MeSH Terms

Conditions

HyperlipidemiasDiabetes MellitusMetabolic SyndromeHypertensionObesity

Interventions

NDC80 protein, human

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Niels Møller, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Oluf B Pedersen, Professor

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

  • Torben Hansen, Professor

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

  • Jørgen Rungby, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

DK(1)