Weight Load PET (WELPET)

Obesity Clinical Trial

— WELPET  

Official title:

Effect of Weight Load on Bone Glucose Uptake in Obese Subjects

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05443620
• Other study ID #: WELPET
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent to participate in the study.

2. Consent out of free will.

3. 18-65 years of age.

4. Maximum body weight of 115 kg.

5. Obesity as defined by a BMI >30 and =35 kg/m2. Fat mass >25 percent of total body weight.

6. Willingness to comply with the study protocol.

7. Confirmation of adequate function of major organs and systems as judged by investigator

8. Normal or clinically non-significant screening of blood samples:

1. 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).

2. Normal or clinically non-significant aberrations of screening blood samples are defined as:

i. Normal: Values within the reference interval supplied by the Turku University Hospital lab.

ii. Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)

Exclusion Criteria:

1. 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.

2. Diagnosed diabetes.

3. 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.

4. 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:

a. ß-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, ß2-agonists, intra articular or parenteral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.

5. Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.

6. Reduced mobility as judged by the investigator.

7. 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.

a. Excessive amounts of alcohol defined as:

i. 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.

8. Change in body weight of =5 kg during the last 3 months.

9. Drastic change in lifestyle during the last 3 months including a significant change in physical activity or dietary habits as judged by the investigator.

10. Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Weight vest
A vest weighing up to a maximum of 15 kg.
• Wheelchair
Wheelchair in which participants will be sitting to reduce loading on lower extremities.

Locations

Country	Name	City	State
Finland	Turku University Hospital, Turku PET Centre	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Göteborg University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View Citation

Ohlsson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 hours
Secondary	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.	3 hours
Secondary	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.	3 hours