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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571609

Enrollment

Registered

2012-04-05

Start date

2012-08-31

Completion date

2014-11-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERfirst 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Diabetes mellitus * Severe illness

Design outcomes

Primary

Measure	Time frame	Description
insulin secretion	10 minutes	Estimation of first phase insulin secretion

Secondary

Measure	Time frame	Description
body composition	60 minutes	Evaluation of body composition using Dxa scan and MRI scan
atherosclerosis	30 minutes	Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
Insulin resistance	240 minutes	Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
Blood pressure	24 hours	Measurement of blood pressure every 20. minutes/24 hours
Indirect calorimetry	60 minutes	Estimation of resting energy expenditure and respiratory quotient
biochemical blood profiling	at baseline	Various tests run on blood samples

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026