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

Sponsor

University of Turku (Other)

Overall Status

Completed

CT.gov ID

NCT03730610

Collaborator

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

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance Type2 Diabetes Exercise Training	Behavioral: Exercise training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Exercise Training for six monthsExercise Training for six months

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 30, 2019

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise intervention Six months of exercise training	Behavioral: Exercise training 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.

Arm

Intervention/Treatment

Experimental: Exercise intervention

Six months of exercise training

Behavioral: Exercise training

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.

Outcome Measures

Primary Outcome Measures

Effects of exercise training - brain glucose uptake [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.
Effects of exercise training - brain inflammation [The change from baseline to 6 months]
Brain inflammation (dimensionless; standistibution volume ratio) is measured with positron emission tomography (PET) with PK11195 tracer

Secondary Outcome Measures

Effects of exercise training - liver glucose uptake [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
Effects of exercise training - adipose tissue glucose uptake [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
Effects of exercise training - whole-body insulin sensitivity [The change from baseline to 6 months]
Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp
Effects of exercise training - ectopic fat [The change from baseline to 6 months]
Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turku	Turku		Finland	20540

Investigators

Principal Investigator: Jarna Hannukainen, PhD, Turku PET Cente, University of Turku, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jarna Hannukainen, Adjunct Professor, University of Turku

ClinicalTrials.gov Identifier:

NCT03730610

Other Study ID Numbers:

317332

First Posted:

Nov 5, 2018

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD: