- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00562796
Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity
Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Prevalence of growth hormone deficiency
Časové okno: Measured at baseline
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Measured at baseline
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines
Časové okno: Measured at baseline
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Measured at baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Steven K. Grinspoon, MD, Program in Nutritional Metabolism, Massachusetts General Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 555
- 1R01HL085268-01A1 (Grant/smlouva NIH USA)
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