Weight Load PET (WELPET)

NCT05443620 | Completed

• 1 other identifier: WELPET
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in glucose uptake in loaded fat tissues

  3 hours

• Change in glucose uptake in loaded muscles

  3 hours

Study Arms (2)

High Load

ACTIVE COMPARATOR

Participants will be standing with a heavy weight vest (11 percent of body weight).

Device: Weight vest

No Load

PLACEBO COMPARATOR

Participants will be sitting.

Device: Wheelchair

Interventions

Weight vest DEVICE

A vest weighing up to a maximum of 15 kg.

High Load

Wheelchair DEVICE

Wheelchair in which participants will be sitting to reduce loading on lower extremities.

No Load

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• Consent out of free will.
• 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.
• 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:
• 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)

You may not qualify if:

• 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:
• a. 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Turku University Hospital, Turku PET Centre

Turku, Finland

Location

Related Publications (3)

• 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.

  PMID: 29279372 BACKGROUND

• 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.

  PMID: 32510046 BACKGROUND

• Bellman 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.

  PMID: 38753869 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Wheelchairs

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Anne Roivainen

  Turku University Hospital, Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All participants will receive both treatments: (1) High load and (2) No load. This at to separate study visits.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2022
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)