Fat Metabolism in OSA and COPD
关键词
抽象
描述
This research study involves 3 visits for subjects and healthy controls. The first visit is the screening visit and includes review of the informed consent and a DXA scan and the second and third visit for the study days. For the first test day, 3 hours of the subjects time will be for urine and blood sample collection, and to stable isotope administration (deuterated water, isotopically labeled amino acids). Subjects are allowed to go home after and eat normally. On the second study day, subjects will arrive early that morning. For the duration of the study, subjects have to lie in the bed (except for bathroom privileges). They can watch tv or bring and use a book/tablet. The research nurse or study staff will be present in the human subject area to assist the subject if necessary. Subjects are not allowed to eat or drink during the second test day, except for the test drink (meal) and water. One IV catheter will be placed in a vein of the arm/hand for blood draws. The hand will be placed in a hot box during blood collection. Another IV catheter will be placed in the contra-lateral forearm for a primed and continuous infusion of isotopes (isotopically labeled amino acids and glycerol). Each day, a total of 80-100 ml of blood will be obtained. Stable isotopes will be ingested and infused on the first test day and added to the test drinks and infused on the second day. On the second test day, subjects will fill out questionnaires. After completion of the study, we will provide the subject with a meal.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 06/03/2014 |
| 提交的预估入学人数: | 06/03/2014 |
| 首次发布: | 06/05/2014 |
| 上次提交的更新: | 06/21/2020 |
| 最近更新发布: | 06/23/2020 |
| 实际学习开始日期: | 03/31/2014 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 01/31/2022 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| COPD and OSA Subjects with diagnosis of COPD and OSA | |
| COPD Subjects with diagnosis of COPD | |
| OSA Subjects with diagnosis of OSA | |
| controls Gender, age, BMI matched controls |
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria subjects: - Established diagnosis of OSA or COPD - Ability to sign informed consent - Ability to walk, sit down and stand up independently - Age 30 years and older - Ability to lie in supine position for up to 8 hours - Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease - Willingness and ability to comply with the protocol Inclusion criteria healthy normal weight and obese subjects: - Healthy male & female according to the investigator's or appointed staff's judgment - Ability to walk, sit down and stand up independently - Age 30 years or older - Ability to lay in supine or elevated position for 8 hours - No diagnosis of OSA or COPD - Willingness and ability to comply with the protocol Exclusion Criteria - Established diagnosis of malignancy - Untreated metabolic diseases including hepatic or renal disorder - Presence of acute illness or metabolically unstable chronic illness - Presence of fever within the last 3 days - Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient - Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment - Use of protein or amino acid containing nutritional supplements within 5 days of first study day 5 days of first study day - Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements - History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime - Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication) - Recent myocardial infarction ( < 1 year ago) - Current alcohol or drug abuse - (Possible) pregnancy |
结果
主要结果指标
1. Hepatic triglyceride synthesis [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
2. Hepatic de novo lipogenesis [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
3. Adipose tissue triglyceride synthesis [pre and 4 hours post meal]
4. Adipose tissue de novo lipogenesis [pre and 4 hours post meal]
5. Adipose tissue lipolysis - glycerol rate of appearance [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
6. Rate of appearance of ingested glucose [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
7. Endogenous Glucose Production [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
8. Glucose disposal [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
9. Net whole-body protein synthesis [0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal]
10. Citrulline Rate of appearance [Postabsorptive state during 2 hours]
11. Arginine turnover rate [postabsorptive state during 3 hours]
12. Whole body collagen breakdown rate [Postabsorptive state during 3 hours]
13. Tryptophan turnover rate [Postabsorptive state during 3 hours]
14. Myofibrillar protein breakdown rate [0,15,30,45,60,75,90,105,120,150,180,210 min post-meal]
15. Glycine rate of appearance [Postabsorptive state during 3 hours]
16. Taurine turnover rate [postabsorptive state during 3 hours]
次要成果指标
1. Fat digestion and absorption [Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion]
2. Insulin response to feeding [pre and up to 5 hours post meal]
3. Body composition [1 day]
4. Physical activity questionnaire [1 day]
5. Protein digestion after feeding [0,15,30,45,60,75,90,105,120,150,180,210, min post-meal]
