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Anti-obesity Treatment by Loading in Adult Subjects (ATLAS)

16 de março de 2022 atualizado por: Vastra Gotaland Region

Effect of Artificial Loading, Through Application of Weight Vests, on Body Weight in Obese Subjects; a Randomized Controlled Trial

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 treatments for 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 body weight. The investigators will also measure food intake, physical activity, energy expenditure, body composition, abdominal fat and heart rate variability. This to further examine the potential beneficial effects of loading and the mechanism of action.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 objectives

To determine if wearing a weight vest with 11 percent of an individual's body weight for up to 5 weeks affects levels of abdominal fat, liver fat, fat mass, fat free mass, physical activity, energy expenditure, waist circumference, food intake or activity in the autonomic nervous system in obese subjects.

To determine, exploratory, if wearing a weight vest with 11 percent of an individual's body weight for up to 5 weeks affects serum concentrations of circulating proteins, metabolites or electrolytes in obese subjects.

STUDY DESIGN AND PROCEDURES

Overall study design and procedure protocol

The aim of the study is to investigate the effect of adding artificial weights to individuals suffering from obesity. Enrolled study subjects will be randomized in a 1:1 fashion to either carry a heavy weight vest with 11 percent of the individual's body weight (intervention group) or a light weight vest with 1 percent of the individual's body weight (control group). The weight vests will be worn for a total of 5 weeks.

Body weight, abdominal fat, liver fat, waist circumference, food intake, energy expenditure, physical activity, activity in the autonomic nervous system, fat mass, bone mass, water mass and fat free mass together with endpoint blood samples will be measured before the start of intervention to obtain base line values. New measurements will then be done for comparison during or after the intervention to determine the effect of added artificial loading on obese subject.

The study consists of a total of 10 weeks. During the first 3 weeks of the study measurements will be made which will be used as baseline. The following 5 weeks contains the intervention and the carrying of a weight vest. The last 2 weeks is a follow up period and at the end of this period follow up measurements will be done. During or after the intervention period new measurements will be made to be compared with the baseline measurements to evaluate the study endpoints.

To avoid the risk of carry-over effects, the investigators have decided to not use a crossover design. This could have decreased the variation of the measurement values and increased the power of the study. However, the investigators believe there could be a risk of a carry-over effect with a cross over design. As this is a completely new effect in clinical studies, the investigators have no information about the wash-out time needed to avoid this problem.

Tipo de estudo

Intervencional

Inscrição (Real)

59

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Västra Götaland
      • Gothenburg, Västra Götaland, Suécia, 405 30
        • Clinical Trial Center, Sahlgrenska University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Signed informed consent to participate in the study.
  2. Consent out of free will.
  3. 18-65 years of age.
  4. Obesity as defined by a BMI >30 and ≤35. Fat mass > 25 %.
  5. Willingness to comply with the study protocol
  6. 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), 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).
    2. 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)

  7. Normal or non-clinically significant 12-lead electrocardiography (ECG) recording as judged by the investigator.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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:

    1. 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.
    2. Any illegal drugs according to local laws and regulation
  4. Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
  5. Reduced mobility.
  6. 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
  7. 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.
  8. 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.

  9. 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.
  10. Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
  11. Having participated in a similar study during the last 6 months.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: High load (11 % of body weight vests)
Subjects in this arm will carry heavy weight (11 percent of body weight) vests for 5 weeks.
Colete com peso máximo de 15 kg.
Outros nomes:
  • Pesos artificiais
Comparador de Placebo: Low load (1 % of body weight vests)
Subjects in this arm will carry heavy weight (1 percent of body weight) vests for 5 weeks.
Colete com peso máximo de 15 kg.
Outros nomes:
  • Pesos artificiais

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in body weight at 5 weeks
Prazo: 35 days
Change in body weight (in percent of baseline body weight) between day 35 and baseline in the high load group compared with low load group.
35 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in body weight at 15 days
Prazo: 15 days
Change in body weight between day 15 and baseline measured in grams.
15 days
Change in subcutaneous fat at 35 days
Prazo: 35 days
Change in levels of subcutaneous fat between day 35 and baseline measured in cm^2 from CT images of the abdomen.
35 days
Change in visceral fat at 35 days
Prazo: 35 days
Change in levels of visceral fat between day 35 and baseline measured in cm^2 from CT images of the abdomen.
35 days
Change in liver fat at 35 days
Prazo: 35 days
Change in levels of liver fat between day 35 and baseline measured in Hounsfield Units (HU) from CT images of the abdomen.
35 days
Change in body composition at 35 days
Prazo: 35 days
Change in levels of fat mass and fat free mass between day 35 and baseline measured in grams with Dual-energy X-ray absorptiometry (DXA).
35 days
Change in waist circumference at 35 days
Prazo: 35 days
Change in waist circumference between day 35 and baseline measured in centimeters with measuring tape.
35 days
Change in physical activity at 21 days
Prazo: 21 days
Change in physical activity between day 21 and baseline. Measured as time distribution in a spectrum of physical activity intensities assessed by accelerometer worn for 24 hours a day for one week. Change measured in minutes per day. Changes compared between measurements during intervention (day 15 to 21) and baseline (day -13 to -7).
21 days
Change in energy expenditure at 28 days
Prazo: 28 days
Change in energy expenditure between day 28 and baseline measured in joules per day with the doubly labeled water method. Changes compared between measurement during intervention (day 14 to 28) and baseline (day -14 to 0).
28 days
Change in food intake at 28 days
Prazo: 28 days
Change in food intake between day 28 and baseline measured in calories with the validated questionnaire Short Dietary Questionnaire (SDQ). Changes compared between measurement during intervention (day 14 to 28) and baseline (day -14 to 0).
28 days
Change in autonomic nervous system activity at 15 days
Prazo: 15 days
Change in heart rate variability (HRV) between day 15 and baseline measured in milliseconds with 24-hour electrocardiography (ECG) monitoring. Changes measured at day 15 compared with baseline (day -13).
15 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Dan Curiac, Clinical Trial Center, Sahlgrenska University Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2021

Conclusão Primária (Real)

3 de fevereiro de 2022

Conclusão do estudo (Real)

3 de fevereiro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

14 de dezembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de janeiro de 2021

Primeira postagem (Real)

6 de janeiro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de março de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de março de 2022

Última verificação

1 de abril de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ATLAS

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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