Weight Gain and Adipose Tissue
Pilot Study to Examine the Effects of Weight Gain on Adipose Tissue
This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood.
The study proposes to investigate the molecular events contributing to increased infiltration of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples after subsequent weight loss will also be examined.
For this study, obesity will be defined by body composition rather than body mass index (BMI), as several studies have shown that BMI does not adequately define obesity and several individuals with normal BMI may indeed have high body fat mass. Individuals with body fat content ≤25% for men, & <35% for women) will be considered lean and individuals with body fat content >25% for men, ≥35% for women will be considered obese.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Age: 18 to 40 (inclusive) years
- BMI 18.5 <30 kg/m2
- Gender: Both males and females will be allowed to participate in the study
- Predominantly sedentary
- Absence of any chronic medical conditions other than seasonal or environmental allergies
- On no prescription medications other than second generation antihistamines (cetirizine , Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices
- Not a current smoker or tobacco user
- Not pregnant or breast feeding and not intending to become pregnant or breast feed
- Lean (low body fat mass) (body fat content ≤ 25% for men, < 35% for women) n=7; Obese (high body fat mass) (body fat content >25% for men, ≥ 35% for women) n=7
- Ability to provide written informed consent
Exclusion Criteria
- Vulnerable study population will be excluded
- Presence of chronic diseases such as diabetes, and cardiovascular disease
- Pregnancy
- Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women)
- Postmenopausal
- Smoking
- Use of chronic Medications (aspirin, statin, anti-inflammatory drugs)
- Subjects found to have significant sleep disorders will be excluded
- Dietary restrictions including lactose intolerance, and vegan diet
- Eating disorders that may interfere with weight gain and weight loss
研究計画
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：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Lean
Lean individuals are defined as having body fat content less or equal to 25% in men and less than 35% for women. Overfeeding induced weight gain and subsequent weight loss |
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実験的：Obese
obese individuals are defined as having body fat content more than 25% in men and more than 35% for women. Overfeeding induced weight gain and subsequent weight loss |
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 from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss.
時間枠：16-20 weeks
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Adipose tissue inflammation will be measures by RTPCR and Western Blot.
These will be presented as ratio to endogenous house keeping gene.
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16-20 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline in blood pressure by 8 week of modest weight gain followed by 8 weeks of weight loss.
時間枠：16-20 weeks
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16-20 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。