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

2022年3月16日 更新者: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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

介入

入学 (実際)

59

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Västra Götaland
      • Gothenburg、Västra Götaland、スウェーデン、405 30
        • Clinical Trial Center, Sahlgrenska University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:High load (11 % of body weight vests)
Subjects in this arm will carry heavy weight (11 percent of body weight) vests for 5 weeks.
重さ15kgまでのベスト。
他の名前:
  • 人工分銅
プラセボコンパレーター:Low load (1 % of body weight vests)
Subjects in this arm will carry heavy weight (1 percent of body weight) vests for 5 weeks.
重さ15kgまでのベスト。
他の名前:
  • 人工分銅

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in body weight at 5 weeks
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in body weight at 15 days
時間枠:15 days
Change in body weight between day 15 and baseline measured in grams.
15 days
Change in subcutaneous fat at 35 days
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Dan Curiac、Clinical Trial Center, Sahlgrenska University Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年9月1日

一次修了 (実際)

2022年2月3日

研究の完了 (実際)

2022年2月3日

試験登録日

最初に提出

2020年12月14日

QC基準を満たした最初の提出物

2021年1月5日

最初の投稿 (実際)

2021年1月6日

学習記録の更新

投稿された最後の更新 (実際)

2022年3月17日

QC基準を満たした最後の更新が送信されました

2022年3月16日

最終確認日

2021年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ATLAS

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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