Skip to main content
OpenTrials
Completed

NCT Number: NCT03730610

Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training

Obesity and insulin resistance are worldwide epidemic and taking a major public health toll. Obesity also increases the risk for cognitive impairment which is also an increasing medical, societal, and economic challenge. The ultimate goal of this proposal is to develop a statistical model to assess systemic cross-talk between brain, peripheral tissues, gut microbiota and glucose metabolism. Integrated with exercise training intervention the results will be utilized to provide disease risk profiling and personalized predictions of exercise training as a drug free treatment for insulin resistance and type 2 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Exercise Training Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2 Diabetes

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, 20540, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • monozygotic twins
  • body mass index (BMI) difference ≥ 2 kg/m2 and/or type 2 diabetes
  • At least one co-twin is overweight (BMI > 25 kg/m2)

Exclusion criteria

  • BMI > 60 kg/m2
  • body weight > 170 kg
  • waist circumference > 150 cm
  • mental disorder or poor compliance
  • eating disorder or excessive use of alcohol
  • active ulcus disease
  • diabetes requiring insulin treatment or fasting glucose > 10 mmol/l
  • pregnancy
  • past dose of radiation
  • claustrophobia
  • presence of ferromagnetic objects that would make MRI contraindicated

Treatment and study plan

Exercise Training

Behavioral

Subjects are required to exercise four times a week during six months. Exercise training consists of endurance training, resistance training and high-intensity interval training adjusted to subject's fitness level.

Primary outcomes

  1. Effects of exercise training - brain glucose uptake

    Time frame: The change from baseline to 6 months

    Brain glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer.

  2. Effects of exercise training - brain inflammation

    Time frame: The change from baseline to 6 months

    Brain inflammation (dimensionless; standistibution volume ratio) is measured with positron emission tomography (PET) with PK11195 tracer

Secondary outcomes

  1. Effects of exercise training - liver glucose uptake

    Time frame: The change from baseline to 6 months

    Liver glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer

  2. Effects of exercise training - adipose tissue glucose uptake

    Time frame: The change from baseline to 6 months

    Adipose tissue glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer

  3. Effects of exercise training - whole-body insulin sensitivity

    Time frame: The change from baseline to 6 months

    Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp

  4. Effects of exercise training - ectopic fat

    Time frame: The change from baseline to 6 months

    Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Academy of Finland
  • Diabetes Research Foundation, Finland
  • Finnish Cultural Foundation
  • Juho Vainio Foundation
  • Turku University Hospital
  • University of Eastern Finland
  • University of Helsinki

Registry information

Official study title

Modelling Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Exercise Training and Public Health

Acronym: CROSSYS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.