drugset / Trial / NCT00131378
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.
Timeline
- Start
- 2004-11
- Primary completion
- 2012-11
- Completion
- 2013-06
Publications
- Dichtel LE, Bjerre M, Schorr M, Bredella MA, Gerweck AV, Russell BM, Frystyk J, Miller KK. The effect of growth hormone on bioactive IGF in overweight/obese women. Growth Horm IGF Res. 2018 Jun;40:20-27. doi: 10.1016/j.ghir.2018.03.003. Epub 2018 Mar 10.
- Bredella MA, Karastergiou K, Bos SA, Gerweck AV, Torriani M, Fried SK, Miller KK. GH administration decreases subcutaneous abdominal adipocyte size in men with abdominal obesity. Growth Horm IGF Res. 2017 Aug;35:17-20. doi: 10.1016/j.ghir.2017.06.001. Epub 2017 Jun 12.
- Bove RM, White CC, Gerweck AV, Mancuso SM, Bredella MA, Sherman JC, Miller KK. Effect of growth hormone on cognitive function in young women with abdominal obesity. Clin Endocrinol (Oxf). 2016 Apr;84(4):635-7. doi: 10.1111/cen.12996. Epub 2016 Feb 2. No abstract available.
- Dichtel LE, Yuen KC, Bredella MA, Gerweck AV, Russell BM, Riccio AD, Gurel MH, Sluss PM, Biller BM, Miller KK. Overweight/Obese adults with pituitary disorders require lower peak growth hormone cutoff values on glucagon stimulation testing to avoid overdiagnosis of growth hormone deficiency. J Clin Endocrinol Metab. 2014 Dec;99(12):4712-9. doi: 10.1210/jc.2014-2830.
- Bredella MA, Gerweck AV, Barber LA, Breggia A, Rosen CJ, Torriani M, Miller KK. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women. Bone. 2014 May;62:29-35. doi: 10.1016/j.bone.2014.01.022. Epub 2014 Feb 5.
- Lin E, Bredella MA, Gerweck AV, Landa M, Schoenfeld D, Utz AL, Miller KK. Effects of growth hormone withdrawal in obese premenopausal women. Clin Endocrinol (Oxf). 2013 Jun;78(6):914-9. doi: 10.1111/cen.12102.
- Bredella MA, Lin E, Brick DJ, Gerweck AV, Harrington LM, Torriani M, Thomas BJ, Schoenfeld DA, Breggia A, Rosen CJ, Hemphill LC, Wu Z, Rifai N, Utz AL, Miller KK. Effects of GH in women with abdominal adiposity: a 6-month randomized, double-blind, placebo-controlled trial. Eur J Endocrinol. 2012 Apr;166(4):601-11. doi: 10.1530/EJE-11-1068. Epub 2012 Jan 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | — | Subcutaneous |