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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance; Exercise Training; Type2 Diabetes
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20540
    • University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of exercise training - brain glucose uptake	Brain glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer.	The change from baseline to 6 months
Effects of exercise training - brain inflammation	Brain inflammation (dimensionless; standistibution volume ratio) is measured with positron emission tomography (PET) with PK11195 tracer	The change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of exercise training - liver glucose uptake	Liver glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer	The change from baseline to 6 months
Effects of exercise training - adipose tissue glucose uptake	Adipose tissue glucose uptake (micromol/100g/min) is measured with positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer	The change from baseline to 6 months
Effects of exercise training - whole-body insulin sensitivity	Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp	The change from baseline to 6 months
Effects of exercise training - ectopic fat	Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)	The change from baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Turku University Hospital; University of Helsinki; University of Eastern Finland; Finnish Cultural Foundation; Academy of Finland; Juho Vainio Foundation; Diabetes Research Foundation, Finland
• Investigators: Principal Investigator: Jarna Hannukainen, PhD, Turku PET Cente, University of Turku, Finland

Publications and helpful links

General Publications

• Heiskanen MA, Honkala SM, Hentila J, Ojala R, Lautamaki R, Koskensalo K, Lietzen MS, Saunavaara V, Saunavaara J, Helmio M, Loyttyniemi E, Nummenmaa L, Collado MC, Malm T, Lahti L, Pietilainen KH, Kaprio J, Rinne JO, Hannukainen JC. Systemic cross-talk between brain, gut, and peripheral tissues in glucose homeostasis: effects of exercise training (CROSSYS). Exercise training intervention in monozygotic twins discordant for body weight. BMC Sports Sci Med Rehabil. 2021 Feb 24;13(1):16. doi: 10.1186/s13102-021-00241-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2019
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (ACTUAL): November 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 317332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD of the main outcome measures will be opened if possible to such as extent that individuals cannot be identified.

Drug and device information, study documents

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