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CompletedNCT03730610CROSSYSUpdated Mar 2, 2022

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

An interventional study of Exercise training in Obesity, Insulin Resistance and Type2 Diabetes, sponsored by University of Turku. Completed at 1 site in Finland. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by University of Turku · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Obesity
  • Insulin Resistance
  • Type2 Diabetes
  • Exercise Training

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In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Exercise intervention

    Six months of exercise training

    Behavioral: Exercise training

Interventions

  • BehavioralExercise 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: The change from baseline to 6 months

  2. Effects of exercise training - brain inflammation

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

    Time frame: The change from baseline to 6 months

Secondary outcomes

  1. 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

    Time frame: The change from baseline to 6 months

  2. 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

    Time frame: The change from baseline to 6 months

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

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

    Time frame: The change from baseline to 6 months

  4. Effects of exercise training - ectopic fat

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

    Time frame: The change from baseline to 6 months

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Study locations

1 site
  • University of Turku
    Turku, 20540, Finland
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References and documents

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. PubMed 33627179 ↗

Individual participant data

Plan to share: Undecided — IPD of the main outcome measures will be opened if possible to such as extent that individuals cannot be identified.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03730610
Lead sponsor
University of Turku
Collaborators
University of Helsinki, University of Eastern Finland, Turku University Hospital, Academy of Finland, Finnish Cultural Foundation, Diabetes Research Foundation, Finland, Juho Vainio Foundation
Responsible party
Jarna Hannukainen (Adjunct Professor, University of Turku) — Principal investigator
First posted
Nov 5, 2018
Start date
Jan 30, 2019
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Mar 2, 2022

Study contacts

Jarna Hannukainen, PhD
principal investigator · Turku PET Cente, University of Turku, Finland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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