Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperlipidemia Diabetes Mellitus Metabolic Syndrome Arterial Hypertension Obesity |
Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders |
- insulin secretion [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]Estimation of first phase insulin secretion
- Insulin resistance [ Time Frame: 240 minutes ] [ Designated as safety issue: Yes ]Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
- body composition [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]Evaluation of body composition using Dxa scan and MRI scan
- atherosclerosis [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
- biochemical blood profiling [ Time Frame: at baseline ] [ Designated as safety issue: No ]Various tests run on blood samples
- Insulin resistance [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
- Blood pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Measurement of blood pressure every 20. minutes/24 hours
- Indirect calorimetry [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]Estimation of resting energy expenditure and respiratory quotient
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Carriers |
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. |
| Experimental: Non-carriers |
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. |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male
- 18-70 years of age
- Member of Biobank Vejle
- BMI<30
Exclusion Criteria:
- Diabetes mellitus
- Severe illness
Contacts and Locations| Denmark | |
| Medicinsk forskningslaboratorium, Aarhus Universitet | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Niels Møller, Professor | University of Aarhus |
| Principal Investigator: | Oluf B Pedersen, Professor | Steno Diabetes Center |
| Principal Investigator: | Torben Hansen, Professor | Steno Diabetes Center |
| Principal Investigator: | Jørgen Rungby, Professor | University of Aarhus |
More Information
Additional Information:
No publications provided
| Responsible Party: | Julie Støy, MD, University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01571609 History of Changes |
| Other Study ID Numbers: | 1-10-72-113-12 |
| Study First Received: | April 3, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperlipidemias Hypertension Metabolic Diseases Obesity Metabolic Syndrome X Glucose Metabolism Disorders Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders |
Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 22, 2013