Clinical trial NCT03730610: Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training
Official title: Modelling Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Exercise Training and Public Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Type2 Diabetes
Exercise Training
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: University of Eastern Finland
name: Turku University Hospital
name: Academy of Finland
name: Finnish Cultural Foundation
name: Diabetes Research Foundation, Finland
name: Juho Vainio Foundation
First posted: 2018-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exercise Training for six months
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effects of exercise training - brain glucose uptake
timeFrame: The change from baseline to 6 months
measure: Effects of exercise training - brain inflammation
timeFrame: The change from baseline to 6 months
Secondary outcomes:
measure: Effects of exercise training - liver glucose uptake
timeFrame: The change from baseline to 6 months
measure: Effects of exercise training - adipose tissue glucose uptake
timeFrame: The change from baseline to 6 months
measure: Effects of exercise training - whole-body insulin sensitivity
timeFrame: The change from baseline to 6 months
measure: Effects of exercise training - ectopic fat
timeFrame: The change from baseline to 6 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Turku PET Cente, University of Turku, Finland
name: Jarna Hannukainen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.