Status:
COMPLETED
Anti-obesity Treatment by Loading in Adult Subjects
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Göteborg University
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the Western World. This trial may result in improved prevention, diagnosis and trea...
Detailed Description
STUDY OBJECTIVES AND ENDPOINTS Primary objective To determine if wearing a weight vest with 11 percent of body weight for 8 hours/day for 5 weeks decreases body weight in obese subjects. Secondary ...
Eligibility Criteria
Inclusion
- Signed informed consent to participate in the study.
- Consent out of free will.
- 18-65 years of age.
- Obesity as defined by a BMI \>30 and ≤35. Fat mass \> 25 %.
- Willingness to comply with the study protocol
- 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), total bilirubin, Prothrombin Time (PT-INR), Activated Partial Thromboplastin Time (APTT), human immunodeficiency viruses (HIV), Hepatitis B, Hepatitis C, glycated hemoglobin (HbA1c), C-reactive protein (CRP), free thyroxine (fT4), thyroid-stimulating hormone (TSH).
- Normal or clinically non-significant aberrations of screening blood samples are defined as:
- i. Normal: Values within the reference interval supplied by the local lab at Sahlgrenska University Hospital
- ii. Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
- Normal or non-clinically significant 12-lead electrocardiography (ECG) recording as judged by the investigator.
Exclusion
- Chronic disease that could interfere with the participation in the study as judged by the investigator. For example poorly regulated type 1 or 2 diabetes, severe cardiovascular disease that effect daily life, severe pulmonary disease that affects daily life or malignancy.
- Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip and knee pain.
- Regular consumption of medicine 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-4 (DPP-IV) inhibitors, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, oral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
- Any illegal drugs according to local laws and regulation
- Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
- Reduced mobility.
- Pregnancy. Females of childbearing potential must confirm to use reliable contraception (intrauterine device, oral contraceptives or condom) and not suspect to be pregnant. Pregnancy test will be taken on all female subjects of fertile age unless permanently sterile, as judged by the investigator. Permanently sterile women can be excluded from the pregnancy test. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
- Change in body weight of 5 kg or greater during the past 3 months or recently started a strict diet. Also, a greater change in body weight than 4 kg difference between day -21 and day 0 will not be accepted.
- Use of any illegal drugs according to local regulations or consuming excessive amounts of alcohol, tobacco, nicotine.
- a. Excessive amounts of above-mentioned substances defined as:
- i. Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 % alcohol) or equivalent as judged by investigator during an ordinary week will not be accepted.
- ii. Individuals with a consumption equal or higher than 10 cigarettes or half a packet of snuff per day.
- Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity, dietary habits, nicotine, alcohol or drug use 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.
- Having participated in a similar study during the last 6 months.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04697238
Start Date
September 1 2021
End Date
February 3 2022
Last Update
March 17 2022
Active Locations (1)
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1
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 405 30