体重、睡眠、心臓の健康
肥満における心血管リスクの概日メカニズム
A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk, with an additional focus on obesity. Specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors. It is intended to compare results in lean and obese individuals to determine if there are specific risks across the circadian cycle specific to obesity. Furthermore, using an exploratory approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.
調査の概要
状態
詳細な説明
Overall, these studies will help us answer whether the circadian system predispose individuals to increased CV disease risk - particularly around the vulnerable morning period, and whether these risks differ with obesity. The results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the CV system that increase effectiveness while decreasing side effects, and may have particular relevance to management of CV risk in people with obesity.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health & Science University
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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
サンプリング方法
調査対象母集団
Community sample
説明
Inclusion Criteria:
- Ages 25-65
- Lean and overweight (BMI 18.5-40kg/m2)
- Habitually sedentary
Exclusion Criteria:
- History of smoking/tobacco use
- Insomnia
- Moderate to severe obstructive sleep apnea.
- Prior shift work within 6 months prior to the study.
- Prescription medications
- Drugs of abuse
- Acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)
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
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Normal Weight
Healthy lean controls [18.5<BMI<25 kg/m2 and waist circumference <94/80 cm (men/women respectively)] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
他の名前：
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Overweight
Healthy obese [30≤BMI<40 and waist circumference ≥94/80 (men and women respectively)] Healthy lean controls [18.5<BMI<25 kg/m2 and waist circumference <94/80 cm (men/women respectively)] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
他の名前：
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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 |
|---|---|---|
|
Blood Pressure (BP)
時間枠：5 Days
|
Measurements were collected up to 7 times per participant across the circadian cycle under constant conditions across 5 days. Resting BP and Exercise BP data were collected at the beginning of each of 7 wake periods in a supine position and where participants exercised at an intensity equivalent to brisk walking. Salivary melatonin was used to calculate the circadian phase marker using dim light melatonin onset (DLMO). All data were assigned a circadian phase relative to DLMO and binned into 4-hour (or 60-degree) intervals. In the statistical analysis, the weight group refers to normal or overweight, exercise condition refers to seated or exercising on the bike, and circadian phase refers to the center of the circadian bin. This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation. |
5 Days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Coronary Microvascular Blood Flux
時間枠：3 days
|
Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography. |
3 days
|
|
Flow Mediated Dilation (FMD)
時間枠：5 days
|
FMD to measure endothelial function. |
5 days
|
|
Heart Rate
時間枠：5 Days
|
Heart rate via 2-channel echocardiogram (ECG) |
5 Days
|
|
Epinephrine
時間枠：5 days
|
Venous Epinephrine to estimate sympathetic output |
5 days
|
|
Norepinephrine
時間枠：5 days
|
Venous Norepinephrine to estimate sympathetic output |
5 days
|
|
Cortisol
時間枠：5 days
|
Saliva cortisol to estimate sympathetic output |
5 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Beta-adrenergic Receptor Density (Exploratory Outcome)
時間枠：5 days.
|
Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging. |
5 days.
|
|
Norepinephrine Reuptake Transport (Exploratory Outcome)
時間枠：5 days.
|
Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging. |
5 days.
|
協力者と研究者
協力者
捜査官
- 主任研究者：Steven A Shea, PhD、Oregon Institute of Occupational Health Sciences
- 主任研究者：Jeanne M Link, PhD、OHSU Center for Radiochemistry Research
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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
- IRB00017489
- KL2TR002370 (米国 NIH グラント/契約)
- R01HL140577 (米国 NIH グラント/契約)
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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