ObesityCROSSYSNCT03730610
Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training
A study testing Exercise training in people with Obesity and Insulin Resistance, run by University of Turku at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Type2 Diabetes
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 30 Jan 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modelling Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Exercise Training and Public Health
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.
- Conditions
- Obesity, Insulin Resistance, Type2 Diabetes, Exercise Training
- Being tested
- Exercise training
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Six months of exercise training Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: The change from baseline to 6 months
Secondary outcomes (4)
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
Measured: The change from baseline to 6 months
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
Measured: The change from baseline to 6 months
Effects of exercise training - whole-body insulin sensitivity
Whole-body insulin sensitivity (M-value; micromol/100g/min) during the hyperinsulinemic euglycemic clamp
Measured: The change from baseline to 6 months
Effects of exercise training - ectopic fat
Ectopic fat content (%) is measured using magnetic resonance spectroscopy (MRS)
Measured: The change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start30 Jan 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exercise Training for six months
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Jarna Hannukainen, University of Turku
- Investigators
- Jarna Hannukainen, PhD, Principal investigator, Turku PET Cente, University of Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730610
- Sponsor's protocol ID
- 317332
- Acronym
- CROSSYS
- Status last verified
- Feb 2022
- First submitted
- 31 Oct 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD of the main outcome measures will be opened if possible to such as extent that individuals cannot be identified.
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Exercise Training and Public Health
- ClinicalTrials.gov ID
- NCT03730610
- Acronym / sponsor ID
- CROSSYS / 317332
- Conditions
- Obesity, Insulin Resistance, Type2 Diabetes, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- University of Helsinki, University of Eastern Finland, Turku University Hospital, Academy of Finland, Finnish Cultural Foundation, Diabetes Research Foundation, Finland, Juho Vainio Foundation
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exercise Training for six months
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise trainingSix months of exercise training |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- BMI > 60 kg/m2
- body weight > 170 kg
- waist circumference > 150 cm
- mental disorder or poor compliance
- eating disorder or excessive use of alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingSubjects 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. | Behavioural | Exercise intervention |
Primary outcome
Effects of exercise training - brain glucose uptake
Time frame: The change from baseline to 6 months
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
Time frame: The change from baseline to 6 months
Brain inflammation (dimensionless; standistibution volume ratio) is measured with positron emission tomography (PET) with PK11195 tracer
4 secondary outcomes
Effects of exercise training - liver glucose uptake
Time frame: The change from baseline to 6 months
Effects of exercise training - adipose tissue glucose uptake
Time frame: The change from baseline to 6 months
Effects of exercise training - whole-body insulin sensitivity
Time frame: The change from baseline to 6 months
Effects of exercise training - ectopic fat
Time frame: The change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 33627179Heiskanen 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarna Hannukainen, PhD principal investigator
Turku PET Cente, University of Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Obesity and Insulin Resistance, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of exercise training - brain glucose uptake (time frame: The change from baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.