Variation of Genes Controlling Carbohydrate and Lipid Metabolism (CMgene)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; PreDiabetes; Lipid Metabolism Disorders

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 Type: Observational
• Enrollment (Anticipated): 2050

Contacts and Locations

• Study Contact: Name: Pirjo R Nuutila, MD, PhD; Phone Number: +35823131868; Email: pirnuu@utu.fi
• Study Contact Backup: Name: Miikka Honka, MSc; Phone Number: +35823132798; Email: mjhonk@utu.fi

Study Locations

• Finland
  • Turku, Finland, 20521
    • Recruiting
    • Turku PET Centre (Turku University Hospital)
    • Contact: Pirjo Nuutila, M.D., Ph.D.; Phone Number: +358 2 2611 868; Email: pirnuu@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population consists of participants of previous studies measuring glucose metabolism, lipid metabolism, bloow flow and adiposity at Turku PET Centre. Important subgroups in this study population are healthy volunteers, participants with obesity, prediabetes, type 2 diabetes or cardiovascular disease.

Description

Inclusion Criteria:

• Previous participation of studies measuring glucose metabolism, lipid metabolism, bloow flow and adiposity at Turku PET Centre

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle insulin sensitivity	Skeletal muscle glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku; Kuopio University Hospital; University of Eastern Finland
• Investigators: Principal Investigator: Pirjo R Nuutila, MD, PhD, Turku PET centre, TurkuUH

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2002
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: genetics; brain; positron emission tomography; liver; skeletal muscle; adipose tissue
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CMgene

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing individual participant data is currently forbidden according to Finnish law.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No