CMgene: Variation of Genes Controlling Carbohydrate and Lipid Metabolism

Sponsor

Turku University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03310502

Collaborator

University of Eastern Finland (Other), Kuopio University Hospital (Other), University of Turku (Other)

2,050

Enrollment

Location

272.5

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) or computed tomography (CT) as part of their previous participation in clinical trials conducted at Turku PET Centre.

By combining information from PET, MRI, CT, proteomics, metabolomics and genetics analyses we aim to find connection between genetic variation and metabolic and cardiovascular disease.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Obesity Insulin Resistance Lipid Metabolism Disorders PreDiabetes

Detailed Description

The data is collected as a separate part of the clinical imaging study protocols using a separate inform consent approved by the local ethics committee. The participation for this study consists of drawing whole blood, serum and plasma samples for genetics, proteomics and metabolomics analyses. The results from these studies are combined with baseline data from the original clinical imaging studies to find connections between genetic variation, metabolism, blood flow and body fat distribution in a cross-sectional setting.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2050 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Variation of Genes Controlling Carbohydrate and Lipid Metabolism

Actual Study Start Date :

Apr 17, 2002

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Skeletal muscle insulin sensitivity [Baseline]
Skeletal muscle glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

Secondary Outcome Measures

Whole body insulin sensitivity [Baseline]
Whole body glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg body weight/min)
Visceral adipose tissue insulin sensitivity to glucose uptake [Baseline]
Visceral adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Abdominal subcutaneous adipose tissue insulin sensitivity to glucose uptake [Baseline]
Abdominal subcutaneous adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Brown adipose tissue insulin sensitivity [Baseline]
Brown adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Brown adipose tissue glucose uptake during cold exposure [Baseline]
Brown adipose tissue glucose uptake during cold exposure (µmol/kg tissue/min)
Insulin sensitivity of adipose tissue lipolysis [Baseline]
Plasma free fatty acid concentration during euglycemic-hyperinsulinemic clamp (mmol/l)
Myocardial insulin sensitivity [Baseline]
Myocardial glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Liver insulin sensitivity to glucose uptake [Baseline]
Liver glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Endogenous glucose production [Baseline]
Endogenous glucose production during euglycemic-hyperinsulinemic clamp (µmol/kg body weight/min)
Brain insulin sensitivity to glucose uptake [Baseline]
Brain glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)
Abdominal subcutaneous adipose tissue mass [Baseline]
Abdominal subcutaneous adipose tissue mass (kg)
Visceral adipose tissue mass [Baseline]
Visceral adipose tissue mass (kg)
Liver fat content [Baseline]
Liver fat percentage (%)
Myocardial fatty acid uptake [Baseline]
Myocardial fatty acid uptake at fasting state (µmol/kg tissue/min)
Liver fatty acid uptake [Baseline]
Liver fatty acid uptake at fasting state (µmol/kg tissue/min)
Abdominal subcutaneous adipose tissue fatty acid uptake [Baseline]
Abdominal subcutaneous adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)
Visceral adipose tissue fatty acid uptake [Baseline]
Visceral adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)
Brown adipose tissue fatty acid uptake at fasting state [Baseline]
Brown adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)
Brown adipose tissue fatty acid uptake during cold exposure [Baseline]
Brown adipose tissue fatty acid uptake at cold exposure (µmol/kg tissue/min)
Skeletal muscle fatty acid uptake [Baseline]
Skeletal muscle fatty acid uptake at fasting state (µmol/kg tissue/min)
Coronary flow reserve [Baseline]
Ratio of myocardial blood flow maximum at stress (ml/g/min) vs. myocardial blood flow at rest (ml/g/min)