Primary outcomeMean· Measured at baseline and month 6
HsCRP
| Group | Value (mg/L) | Spread |
|---|---|---|
| Male on GH | -1.1 | 0.5 |
| Male on Placebo | 0.5 | 0.3 |
| Female on GH | -1.3 | 0.2 |
| Female on Placebo | -0.3 | 0.2 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataGrowth Hormone, Cardiovascular Risk, and Visceral Adiposity
NCTNCT00131378 (opens ClinicalTrials.gov in a new tab)Other id525Other idMGH GCRC 678Other id2004-P-000013Other idR01HL077674
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 142 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Nov 2004
- Primary completion
- Nov 2012
- Completion
- Jun 2013
- First posted
- 18 Aug 2005 (estimated)
- Last update posted
- 11 Mar 2016 (estimated)
- Conditions
- Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200420062008201020122014
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Nutropin AQ growth hormoneDrug
- Placebo Growth HormoneDrug
Arms4
Experimental
Male on GH
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
Placebo comparator
Male on Placebo
Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
Experimental
Female on GH
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
Placebo comparator
Female on Placebo
Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
Primary outcomes3
Outcomes the sponsor listed as primary.
HsCRP
Time frame · Measured at baseline and month 6
Registry description
6 month change in HsCRP (primary cardiovascular risk endpoint)
Total Abdominal Fat
Time frame · Measured at baseline and month 6
Registry description
6 month change in total abdominal fat (primary body composition endpoint)
Abdominal Fat
Time frame · Measured at baseline and month 6
Registry description
6 month change in visceral abdominal fat (primary body composition endpoint)
Secondary outcomes(2)
Measure of Insulin Resistance
Time frame · Measured at baseline and month 6
Registry description
6 month change in 2-hour glucose (primary insulin resistance endpoint)
Insulin-like Growth Factor-1 (IGF-1) Levels
Time frame · Measured at baseline and month 6
Registry description
6-month change in IGF-1 levels
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Measured at baseline and month 6
Total Abdominal Fat
| Group | Value (cm^2) | Spread |
|---|---|---|
| Female on GH | -28.0 | 9.7 |
| Female on Placebo | 1.5 | 11 |
Primary outcomeMean· Measured at baseline and month 6
Abdominal Fat
| Group | Value (cm^2) | Spread |
|---|---|---|
| Male on GH | -15.9 | 6.3 |
| Male on Placebo | -0.2 | 7.2 |
Secondary and other outcome results(2)
Secondary outcomeMean· Measured at baseline and month 6
Measure of Insulin Resistance
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Male on GH | 5.3 | 5.6 |
| Male on Placebo | -12.5 | 5.8 |
| Female on GH | 18.6 | 6.3 |
| Female on Placebo | -0.9 | 8.2 |
Secondary outcomeMean· Measured at baseline and month 6
Insulin-like Growth Factor-1 (IGF-1) Levels
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Male on GH | 179.0 | 31.5 |
| Male on Placebo | 9.9 | 7.8 |
| Female on GH | 106.5 | 17.5 |
| Female on Placebo | -20.8 | 7.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Female on GHParticipants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. | – | 0 / 40 | 4 / 40 |
| Female on PlaceboParticipants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | – | 1 / 40 | 3 / 40 |
| Male on GHParticipants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. | – | 0 / 32 | 7 / 32 |
| Male on PlaceboParticipants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | – | 1 / 30 | 3 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedDichtel 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. PMID 29679919
- DerivedBredella 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. PMID 28628810
- DerivedBove 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. PMID 26663235
- DerivedDichtel 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. PMID 25210883
- DerivedBredella 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. PMID 24508386
- DerivedLin 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. PMID 23146135
- DerivedBredella 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. PMID 22275471
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 45 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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