Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-01 @ 3:20 AM
Study NCT ID:
NCT05443620
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Load PET (WELPET)
Sponsor:
Turku University Hospital
Organization:
Study Overview
Official Title:
Effect of Weight Load on Bone Glucose Uptake in Obese Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WELPET
Brief 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. 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.
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
1. 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
2. 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.
3. 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:
1. No load - Participant in sitting position.
2. 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.
Primary objective
1. 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
2. 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.
3. 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:
1. No load - Participant in sitting position.
2. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: