search
Back to results

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

Primary Purpose

Hyperlipidemia, Diabetes Mellitus, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperlipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes mellitus
  • Severe illness

Sites / Locations

  • Medicinsk forskningslaboratorium, Aarhus Universitet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carriers

Non-carriers

Arm Description

Outcomes

Primary Outcome Measures

insulin secretion
Estimation of first phase insulin secretion

Secondary Outcome Measures

Insulin resistance
Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
body composition
Evaluation of body composition using Dxa scan and MRI scan
atherosclerosis
Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
biochemical blood profiling
Various tests run on blood samples
Insulin resistance
Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
Blood pressure
Measurement of blood pressure every 20. minutes/24 hours
Indirect calorimetry
Estimation of resting energy expenditure and respiratory quotient

Full Information

First Posted
April 3, 2012
Last Updated
December 1, 2014
Sponsor
University of Aarhus
Collaborators
Lundbeck Foundation, Aarhus University Hospital, Vejle Hospital, Hospital of South West Jutland, Steno Diabetes Center Copenhagen, University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT01571609
Brief Title
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Official Title
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Lundbeck Foundation, Aarhus University Hospital, Vejle Hospital, Hospital of South West Jutland, Steno Diabetes Center Copenhagen, University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Diabetes Mellitus, Metabolic Syndrome, Arterial Hypertension, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carriers
Arm Type
Experimental
Arm Title
Non-carriers
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
Intervention Description
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 Outcome Measure Information:
Title
insulin secretion
Description
Estimation of first phase insulin secretion
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
Time Frame
240 minutes
Title
body composition
Description
Evaluation of body composition using Dxa scan and MRI scan
Time Frame
60 minutes
Title
atherosclerosis
Description
Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
Time Frame
30 minutes
Title
biochemical blood profiling
Description
Various tests run on blood samples
Time Frame
at baseline
Title
Insulin resistance
Description
Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
Time Frame
60 minutes
Title
Blood pressure
Description
Measurement of blood pressure every 20. minutes/24 hours
Time Frame
24 hours
Title
Indirect calorimetry
Description
Estimation of resting energy expenditure and respiratory quotient
Time Frame
60 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male 18-70 years of age Member of Biobank Vejle BMI<30 Exclusion Criteria: Diabetes mellitus Severe illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oluf B Pedersen, Professor
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Torben Hansen, Professor
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jørgen Rungby, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicinsk forskningslaboratorium, Aarhus Universitet
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26336608
Citation
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.
Results Reference
derived
PubMed Identifier
25314291
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs