Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training (CROSSYS)
Primary Purpose
Obesity, Insulin Resistance, Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
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
Sites / Locations
- University of Turku
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise intervention
Arm Description
Six months of exercise training
Outcomes
Primary Outcome Measures
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.
Effects of exercise training - brain inflammation
Brain inflammation (dimensionless; standistibution volume ratio) is measured with positron emission tomography (PET) with PK11195 tracer
Secondary Outcome Measures
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
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
Effects of exercise training - whole-body insulin sensitivity
Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp
Effects of exercise training - ectopic fat
Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)
Full Information
NCT ID
NCT03730610
First Posted
October 31, 2018
Last Updated
February 25, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT03730610
Brief Title
Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training
Acronym
CROSSYS
Official Title
Modelling Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Exercise Training and Public Health
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Type2 Diabetes, Exercise Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exercise Training for six months
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
Six months of exercise training
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effects of exercise training - brain glucose uptake
Description
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
Title
Effects of exercise training - brain inflammation
Description
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 Outcome Measure Information:
Title
Effects of exercise training - liver glucose uptake
Description
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
Title
Effects of exercise training - adipose tissue glucose uptake
Description
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
Title
Effects of exercise training - whole-body insulin sensitivity
Description
Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp
Time Frame
The change from baseline to 6 months
Title
Effects of exercise training - ectopic fat
Description
Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)
Time Frame
The change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarna Hannukainen, PhD
Organizational Affiliation
Turku PET Cente, University of Turku, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20540
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD of the main outcome measures will be opened if possible to such as extent that individuals cannot be identified.
Citations:
PubMed Identifier
33627179
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.
Results Reference
derived
Learn more about this trial
Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training
We'll reach out to this number within 24 hrs