NCT03730610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

October 31, 2018

Last Update Submit

February 25, 2022

Conditions

ObesityInsulin ResistanceType2 DiabetesExercise Training

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Effects of exercise training - liver glucose uptake

    The change from baseline to 6 months

  • Effects of exercise training - adipose tissue glucose uptake

    The change from baseline to 6 months

  • Effects of exercise training - whole-body insulin sensitivity

    The change from baseline to 6 months

  • Effects of exercise training - ectopic fat

    The change from baseline to 6 months

Study Arms (1)

Exercise intervention

EXPERIMENTAL

Six months of exercise training

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

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.

Exercise intervention

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20540, Finland

Location

Related Publications (1)

  • 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.

    PMID: 33627179DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jarna Hannukainen, PhD

    Turku PET Cente, University of Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Exercise Training for six months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 5, 2018

Study Start

January 30, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

FI(1)