Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity
Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity
調査の概要
詳細な説明
Obesity is associated with significant morbidity and mortality and is a primary public health concern. Both the incidence and prevalence of obesity have increased over the last several decades, with obesity now affecting an estimated 31% of the American population. Recent data suggest that people with abdominal obesity commonly exhibit low levels of GH, which affects the body's growth rate and the way the body uses food for energy. Low GH levels and excess abdominal fat have been linked to improper functioning of the cardiovascular system and, therefore, may increase one's risk of cardiovascular disease. This study will determine the prevalence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.
Participation in this observational study will last between 2 and 4 weeks. The study will consist of two outpatient visits, held at either the Massachusetts General Hospital or Massachusetts Institute of Technology. Visit 1 will last 4 hours and will include a physical exam, medical history, blood draw, urine sampling, indirect calorimetry test, and growth hormone releasing hormone (GHRH)+Arginine stimulation test. Eligible participants will return within the next 3 weeks for Visit 2, which will last 5 hours. Before the second visit, participants will be asked to record their food intake for 4 days on a food record. During the visit, participants will have a repeat physical exam, urine sampling, and blood draw. Participants will also undergo an oral glucose tolerance test, whole body DEXA scan, abdominal computed tomography (CT) scan, and a carotid ultrasound. Participation in the study will end after Visit 2.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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
説明
Inclusion Criteria for Obesity:
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Abdominal obesity, defined as waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women
Inclusion Criteria for Lean Controls:
- BMI less than 25 kg/m2
- Waist circumference less than 102 cm in men and less than 88 cm in women
Exclusion Criteria for both groups:
- Obesity due to known secondary causes
- Taking any weight lowering drugs
- Previous bariatric surgery
- Use of the following compounds within the 3 months prior to study entry: estrogen, progesterone, GH, GHRH, glucocorticoids, megesterol acetate, antidiabetic agents, oral contraceptive pills, or any other hormone or drug known to affect GH levels
- Change in lipid lowering or antihypertensive regimen within 3 months prior to study entry
- Use of testosterone or hormone replacement therapy
- Previously known diabetes mellitus or other severe chronic illness
- Hemoglobin less than 11.0 g/dL, creatinine greater than 1.5 mg/dL, or serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times the upper limit of normal
- Follicle stimulating hormone (FSH) greater than 20 IU/L in women
- Positive urine pregnancy test
- Prior history of pituitary disease, pituitary surgery, head irradiation, or any other condition known to affect the GH axis
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
コホートと介入
グループ/コホート |
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1
Participants with abdominal obesity without growth hormone deficiency
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2
Participants with abdominal obesity with growth hormone deficiency
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3
Participants who are lean controls
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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 |
時間枠 |
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Prevalence of growth hormone deficiency
時間枠:Measured at baseline
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Measured at baseline
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二次結果の測定
結果測定 |
時間枠 |
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Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines
時間枠:Measured at baseline
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Measured at baseline
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協力者と研究者
捜査官
- 主任研究者:Steven K. Grinspoon, MD、Program in Nutritional Metabolism, Massachusetts General Hospital
出版物と役立つリンク
一般刊行物
- Stanley TL, Feldpausch MN, Murphy CA, Grinspoon SK, Makimura H. Discordance of IGF-1 and GH stimulation testing for altered GH secretion in obesity. Growth Horm IGF Res. 2014 Feb;24(1):10-5. doi: 10.1016/j.ghir.2013.11.001. Epub 2013 Nov 15.
- Makimura H, Feldpausch MN, Stanley TL, Sun N, Grinspoon SK. Reduced growth hormone secretion in obesity is associated with smaller LDL and HDL particle size. Clin Endocrinol (Oxf). 2012 Feb;76(2):220-7. doi: 10.1111/j.1365-2265.2011.04195.x.
- Makimura H, Stanley TL, Sun N, Connelly JM, Hemphill LC, Hrovat MI, Systrom DM, Grinspoon SK. Increased skeletal muscle phosphocreatine recovery after sub-maximal exercise is associated with increased carotid intima-media thickness. Atherosclerosis. 2011 Mar;215(1):214-7. doi: 10.1016/j.atherosclerosis.2010.11.037. Epub 2010 Dec 5.
- Makimura H, Stanley TL, Sun N, Connelly JM, Hemphill LC, Grinspoon SK. The relationship between reduced testosterone, stimulated growth hormone secretion and increased carotid intima-media thickness in obese men. Clin Endocrinol (Oxf). 2010 Nov;73(5):622-9. doi: 10.1111/j.1365-2265.2010.03859.x.
- Makimura H, Stanley T, Mun D, Chen C, Wei J, Connelly JM, Hemphill LC, Grinspoon SK. Reduced growth hormone secretion is associated with increased carotid intima-media thickness in obesity. J Clin Endocrinol Metab. 2009 Dec;94(12):5131-8. doi: 10.1210/jc.2009-1295. Epub 2009 Oct 16.
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 (見積もり)
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
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