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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571609
• Other study ID #: 1-10-72-113-12
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: December 1, 2014
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male

• 18-70 years of age

• Member of Biobank Vejle

• BMI<30

Exclusion Criteria:

• Diabetes mellitus

• Severe illness

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Metabolic Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Other:
• first 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.

Locations

Country	Name	City	State
Denmark	Medicinsk forskningslaboratorium, Aarhus Universitet	Aarhus

Sponsors (7)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Lundbeck Foundation, Steno Diabetes Center, Sydvestjysk Hospital, University of Copenhagen, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin secretion	Estimation of first phase insulin secretion	10 minutes	No
Secondary	Insulin resistance	Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers	240 minutes	Yes
Secondary	body composition	Evaluation of body composition using Dxa scan and MRI scan	60 minutes	No
Secondary	atherosclerosis	Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery	30 minutes	No
Secondary	biochemical blood profiling	Various tests run on blood samples	at baseline	No
Secondary	Insulin resistance	Biopsi from muscle and adipose tissue performed at baseline and during clamp study.	60 minutes	Yes
Secondary	Blood pressure	Measurement of blood pressure every 20. minutes/24 hours	24 hours	No
Secondary	Indirect calorimetry	Estimation of resting energy expenditure and respiratory quotient	60 minutes	No

External Links

•   Project home page