ObesityWELPETNCT05443620
Weight Load PET (WELPET)
A study testing Weight vest and Wheelchair in people with Obesity, run by Turku University Hospital at 1 site in Finland.
Trial summary
Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the world. This trial may result in improved understanding of the causes of obesity and obesity-related disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight vest and Wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2022to 22 Nov 2024
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent to participate in the study.
- Consent out of free will.
- 18-65 years of age.
- Maximum body weight of 115 kg.
- Obesity as defined by a BMI >30 and ≤35 kg/m2. Fat mass >25 percent of total body weight.
- Willingness to comply with the study protocol.
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- Confirmation of adequate function of major organs and systems as judged by investigator
- Normal or clinically non-significant screening of blood samples:
- Hemoglobin (Hb), White Blood Cell Count (WBC), thrombocyte count, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), creatinine, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), glycated hemoglobin (HbA1c), fasting blood glucose, C-reactive protein (CRP), free thyroxine (fT4), thyroid stimulating hormone (TSH), Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL).
- Normal or clinically non-significant aberrations of screening blood samples are defined as:
- Normal: Values within the reference interval supplied by the Turku University Hospital lab.
- Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
Who cannot join
- Chronic disease that could interfere with the participation in the study as judged by the investigator such as neurological, renal, hepatic, endocrine, cardiovascular, pulmonary, hematological, or gastrointestinal disorders.
- Diagnosed diabetes.
- Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip or knee pain.
- Regular consumption of medications or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
- β-blockers, Glucagon-Like Peptide 1 (GLP-1)-agonists, Dipeptidyl Peptidase-IV (DPP-IV)-inhibitors, Sodium-glucose Cotransporter-2 (SGLT2)-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, intra articular or parenteral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
- Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
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- Reduced mobility as judged by the investigator.
- Use of any illegal drugs according to local regulations, use of tobacco or nicotine products (e.g. cigarettes or snuff) or consuming excessive amounts of alcohol.
- Excessive amounts of alcohol defined as:
- Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 percent alcohol) or equivalent as judged by the investigator during an ordinary week will not be accepted.
- Change in body weight of ≥5 kg during the last 3 months.
- Drastic change in lifestyle during the last 3 months including a significant change in physical activity or dietary habits as judged by the investigator.
- Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weight Load on Bone Glucose Uptake in Obese Subjects
Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the world. This trial may result in improved understanding of the causes of obesity and obesity-related disorders. Published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. Recently published data further show comparable results in humans when carrying an additional weight.
The investigators aim to confirm and further investigate these findings in humans. The investigators plan to let obese participants carry weight vests and monitor their change in glucose uptake in different tissues. This to further examine the effects increased axial loading has on glucose metabolism in different parts of the body.
Read the detailed description
STUDY OBJECTIVES AND ENDPOINTS
Primary objective
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in bone more than sitting (no load) for 3 hours. Secondary objectives
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in fat tissue more than sitting (no load) for 3 hours.
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in muscle more than sitting (no load) for 3 hours.
STUDY DESIGN AND PROCEDURES
Overall study design and procedure protocol
This is an interventional, single center, imaging study with a within-subjects design. The aim is to investigate how increased loading affects the glucose uptake in the weight bearing bones measured with whole-body Positron Emission Tomography (PET)/Computed Tomography (CT) imaging together with the Fluorine-18 labeled glucose analog, 2-deoxy-2-[18F]-fluoro-D-glucose (18F-FDG). Glucose uptake in muscle and fat tissues will also be evaluated. All participants will test 2 different conditions with measurements of bone glucose uptake after:
- No load - Participant in sitting position.
- High load - Standing with a heavy weight vest consisting of 11 percent of the participants body weight.
Participants will receive loading for 3 hours before measurement with PET/CT imaging. Weight of weight vest are based on participants' body weight at the high load visit. Participants will continue with their normal lifestyle during the whole study. There will be a total of three study visits. Study visits will be on 3 separate days within approximately 3 weeks with a minimum of 2 days between each visit. Visits after screening will occur in a randomised order for all participants. All participants will undergo both study treatments and measurements will be compared within each participant from high load and no load visit.
- Conditions
- Obesity
- Being tested
- Weight vest, Wheelchair
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight vestDevice
A vest weighing up to a maximum of 15 kg.
WheelchairDevice
Wheelchair in which participants will be sitting to reduce loading on lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| High Load | Active comparator | Participants will be standing with a heavy weight vest (11 percent of body weight). Receives: Device: Weight vest |
| No Load | Placebo comparator | Participants will be sitting. Receives: Device: Wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose uptake in loaded bones
Change in ratio between glucose uptake in loaded bones (e.g. femur, tibia) and glucose uptake in not loaded bones (e.g. humerus). Change in ratio (in percent between high load and no load) compared after 3 hours of different interventions.
Measured: 3 hours
Secondary outcomes (2)
Change in glucose uptake in loaded fat tissues
Change in ratio between glucose uptake in loaded fat tissues (e.g. subcutaneous (thigh \& abdominal) and visceral) and glucose uptake in not loaded fat tissues (e.g. subcutaneous arm). Change in ratio (in percent between high load and no load) compared after 3 hours of different interventions.
Measured: 3 hours
Change in glucose uptake in loaded muscles
Change in ratio between glucose uptake in loaded muscles (e.g. m. quadriceps femoris, m. hamstrings, m. soleus) and glucose uptake in not loaded muscles (e.g. m. biceps brachii, m. triceps brachii). Change in ratio (in percent between high load and no load) compared after 3 hours of different interventions.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants will receive both treatments: (1) High load and (2) No load. This at to separate study visits.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Anne Roivainen, Principal investigator, Turku University Hospital, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443620
- Sponsor's protocol ID
- WELPET
- Acronym
- WELPET
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansson JO, Palsdottir V, Hagg DA, Schele E, Dickson SL, Anesten F, Bake T, Montelius M, Bellman J, Johansson ME, Cone RD, Drucker DJ, Wu J, Aleksic B, Tornqvist AE, Sjogren K, Gustafsson JA, Windahl SH, Ohlsson C. Body weight homeostat that regulates fat mass independently of leptin in rats and mice. Proc Natl Acad Sci U S A. 2018 Jan 9;115(2):427-432. doi: 10.1073/pnas.1715687114. Epub 2017 Dec 26.
PubMed 29279372Ohlsson C, Gidestrand E, Bellman J, Larsson C, Palsdottir V, Hagg D, Jansson PA, Jansson JO. Increased weight loading reduces body weight and body fat in obese subjects - A proof of concept randomized clinical trial. EClinicalMedicine. 2020 Apr 30;22:100338. doi: 10.1016/j.eclinm.2020.100338. eCollection 2020 May.
PubMed 32510046Bellman J, Sjoros T, Hagg D, Atencio Herre E, Hieta J, Eskola O, Laitinen K, Nuutila P, Jansson JO, Jansson PA, Kalliokoski K, Roivainen A, Ohlsson C. Loading Enhances Glucose Uptake in Muscles, Bones, and Bone Marrow of Lower Extremities in Humans. J Clin Endocrinol Metab. 2024 Nov 18;109(12):3126-3136. doi: 10.1210/clinem/dgae344.
PubMed 38753869
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Load on Bone Glucose Uptake in Obese Subjects
- ClinicalTrials.gov ID
- NCT05443620
- Acronym / sponsor ID
- WELPET / WELPET
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Göteborg University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 5 Jul 2022 (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 related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the world. This trial may result in improved understanding of the causes of obesity and obesity-related disorders. Published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. Recently published data further show comparable results in humans when carrying an additional weight.
The investigators aim to confirm and further investigate these findings in humans. The investigators plan to let obese participants carry weight vests and monitor their change in glucose uptake in different tissues. This to further examine the effects increased axial loading has on glucose metabolism in different parts of the body.
Detailed description
STUDY OBJECTIVES AND ENDPOINTS
Primary objective
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in bone more than sitting (no load) for 3 hours. Secondary objectives
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in fat tissue more than sitting (no load) for 3 hours.
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in muscle more than sitting (no load) for 3 hours.
STUDY DESIGN AND PROCEDURES
Overall study design and procedure protocol
This is an interventional, single center, imaging study with a within-subjects design. The aim is to investigate how increased loading affects the glucose uptake in the weight bearing bones measured with whole-body Positron Emission Tomography (PET)/Computed Tomography (CT) imaging together with the Fluorine-18 labeled glucose analog, 2-deoxy-2-[18F]-fluoro-D-glucose (18F-FDG). Glucose uptake in muscle and fat tissues will also be evaluated. All participants will test 2 different conditions with measurements of bone glucose uptake after:
- No load - Participant in sitting position.
- High load - Standing with a heavy weight vest consisting of 11 percent of the participants body weight.
Participants will receive loading for 3 hours before measurement with PET/CT imaging. Weight of weight vest are based on participants' body weight at the high load visit. Participants will continue with their normal lifestyle during the whole study. There will be a total of three study visits. Study visits will be on 3 separate days within approximately 3 weeks with a minimum of 2 days between each visit. Visits after screening will occur in a randomised order for all participants. All participants will undergo both study treatments and measurements will be compared within each participant from high load and no load visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive both treatments: (1) High load and (2) No load. This at to separate study visits.
| Arm | Type | Receives |
|---|---|---|
| High Load | Active comparator | Device: Weight vestParticipants will be standing with a heavy weight vest (11 percent of body weight). |
| No Load | Placebo comparator | Device: WheelchairParticipants will be sitting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent to participate in the study.
- Consent out of free will.
- 18-65 years of age.
- Maximum body weight of 115 kg.
- Obesity as defined by a BMI >30 and ≤35 kg/m2. Fat mass >25 percent of total body weight.
Key exclusion criteria (13 listed)
- Chronic disease that could interfere with the participation in the study as judged by the investigator such as neurological, renal, hepatic, endocrine, cardiovascular, pulmonary, hematological, or gastrointestinal disorders.
- Diagnosed diabetes.
- Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip or knee pain.
- Regular consumption of medications or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
- Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
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 |
|---|---|---|
| Weight vestA vest weighing up to a maximum of 15 kg. | Device | High Load |
| WheelchairWheelchair in which participants will be sitting to reduce loading on lower extremities. | Device | No Load |
Primary outcome
Change in glucose uptake in loaded bones
Time frame: 3 hours
Change in ratio between glucose uptake in loaded bones (e.g. femur, tibia) and glucose uptake in not loaded bones (e.g. humerus). Change in ratio (in percent between high load and no load) compared after 3 hours of different interventions.
2 secondary outcomes
Change in glucose uptake in loaded fat tissues
Time frame: 3 hours
Change in glucose uptake in loaded muscles
Time frame: 3 hours
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 15 Jan 2025.
- Background: PubMed 29279372Jansson JO, Palsdottir V, Hagg DA, Schele E, Dickson SL, Anesten F, Bake T, Montelius M, Bellman J, Johansson ME, Cone RD, Drucker DJ, Wu J, Aleksic B, Tornqvist AE, Sjogren K, Gustafsson JA, Windahl SH, Ohlsson C. Body weight homeostat that regulates fat mass independently of leptin in rats and mice. Proc Natl Acad Sci U S A. 2018 Jan 9;115(2):427-432. doi: 10.1073/pnas.1715687114. Epub 2017 Dec 26.
- Background: PubMed 32510046Ohlsson C, Gidestrand E, Bellman J, Larsson C, Palsdottir V, Hagg D, Jansson PA, Jansson JO. Increased weight loading reduces body weight and body fat in obese subjects - A proof of concept randomized clinical trial. EClinicalMedicine. 2020 Apr 30;22:100338. doi: 10.1016/j.eclinm.2020.100338. eCollection 2020 May.
- Derived from this study: PubMed 38753869Bellman J, Sjoros T, Hagg D, Atencio Herre E, Hieta J, Eskola O, Laitinen K, Nuutila P, Jansson JO, Jansson PA, Kalliokoski K, Roivainen A, Ohlsson C. Loading Enhances Glucose Uptake in Muscles, Bones, and Bone Marrow of Lower Extremities in Humans. J Clin Endocrinol Metab. 2024 Nov 18;109(12):3126-3136. doi: 10.1210/clinem/dgae344.
- Individual participant dataSharing planned: No
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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.
Anne Roivainen principal investigator
Turku University Hospital, Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight vest and Wheelchair in people with Obesity, run by Turku University Hospital 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 12 inclusion and 13 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 15 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Change in glucose uptake in loaded bones (time frame: 3 hours). 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 NCT05443620, which also lists 3 linked publications.
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 15 Jan 2025.