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

Obesity Clinical Trial

— CROSSYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730610
• Other study ID #: 317332
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Training
• Insulin Resistance
• Obesity
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (8)

Lead Sponsor	Collaborator
University of Turku	Academy of Finland, Diabetes Research Foundation, Finland, Finnish Cultural Foundation, Juho Vainio Foundation, Turku University Hospital, University of Eastern Finland, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Effects of exercise training - ectopic fat	Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)	The change from baseline to 6 months