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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Arterial Hypertension; Hyperlipidemia; Metabolic Syndrome; Obesity
• Interventions: Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer

• Registration Number: NCT01571609
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Study Start: 2012-08
• Primary Completion: 2013-07
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

Read More

Exclusion Criteria

• Diabetes mellitus
• Severe illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-carriers	first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer	-
Carriers	first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer	-

Primary Outcome Measures

Name	Time	Method
insulin secretion	10 minutes	Estimation of first phase insulin secretion

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	60 minutes	Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
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
biochemical blood profiling	at baseline	Various tests run on blood samples
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

Trial Locations

Locations (1)

Medicinsk forskningslaboratorium, Aarhus Universitet; 🇩🇰 Aarhus, Denmark