Clinical trial NCT00131378: Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Official title: Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Visceral obesity
Growth hormone
Cardiovascular risk
Insulin resistance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2005-08-18
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. Study subjects will be followed for an additional six months for these endpoints.

Eligibility criteria: Inclusion Criteria:

* For growth hormone measurement part (for men and women):

  1. For visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and BMI greater than or equal to 25 kg/m2
  2. For lean controls: BMI 18.5 to 24.9 kg/m2
* For growth hormone treatment part (for men and women):

  1. Visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, BMI greater than or equal to 25 kg/m2)
  2. IGF-I within the lowest 2 quartiles for age and gender
  3. Willingness to maintain current activity level and diet

Exclusion Criteria:

* Diabetes mellitus (fasting plasma glucose greater than 126 mg/dL or 2-hour post-oral glucose tolerance test \[OGTT\] plasma glucose greater than 200)
* Taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight
* Smoking
* Hematocrit below the lower limit of normal
* Amenorrhea for 3 months (in women)
* Pregnant or breastfeeding (in women)
* Polycystic ovary syndrome (in women)
* Weight that exceeds 280 pounds
* SGPT greater than 2 times the upper limit of normal
* History of malignancy, except for fully resolved basal cell carcinomas of the skin (Specific Aim 2 only)
* Radiation exposure greater than 1000 mrem over the last 12 months
* Previous diagnosis of cardiovascular disease
* History of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency
* History of carpal tunnel syndrome that has not been surgically treated

Primary outcomes:
measure: HsCRP
timeFrame: Measured at baseline and month 6
measure: Total Abdominal Fat
timeFrame: Measured at baseline and month 6
measure: Abdominal Fat
timeFrame: Measured at baseline and month 6
Secondary outcomes:
measure: Measure of Insulin Resistance
timeFrame: Measured at baseline and month 6
measure: Insulin-like Growth Factor-1 (IGF-1) Levels
timeFrame: Measured at baseline and month 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen K. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.