ObesityNCT00131378
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
A study testing Nutropin AQ growth hormone in people with Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutropin AQ growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For growth hormone measurement part (for men and women):
- 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
- For lean controls: BMI 18.5 to 24.9 kg/m2
- For growth hormone treatment part (for men and women):
- 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)
- IGF-I within the lowest 2 quartiles for age and gender
- Willingness to maintain current activity level and diet
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Nutropin AQ growth hormone, Placebo Growth Hormone
- Keywords
- Visceral obesity, Growth hormone, Cardiovascular risk, Insulin resistance
- Medical subject headings
- Obesity, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutropin AQ growth hormoneDrug
Participants will give themselves injections of growth hormone every night for 6 months.
Placebo Growth HormoneDrug
Participants will give themselves injections of placebo growth hormone every night for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Male on GH | Experimental | 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. Receives: Drug: Nutropin AQ growth hormone |
| Male on Placebo | Placebo comparator | Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. Receives: Drug: Placebo Growth Hormone |
| Female on GH | Experimental | 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. Receives: Drug: Nutropin AQ growth hormone |
| Female on Placebo | Placebo comparator | Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. Receives: Drug: Placebo Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HsCRP
6 month change in HsCRP (primary cardiovascular risk endpoint)
Measured: Measured at baseline and month 6
Total Abdominal Fat
6 month change in total abdominal fat (primary body composition endpoint)
Measured: Measured at baseline and month 6
Abdominal Fat
6 month change in visceral abdominal fat (primary body composition endpoint)
Measured: Measured at baseline and month 6
Secondary outcomes (2)
Measure of Insulin Resistance
6 month change in 2-hour glucose (primary insulin resistance endpoint)
Measured: Measured at baseline and month 6
Insulin-like Growth Factor-1 (IGF-1) Levels
6-month change in IGF-1 levels
Measured: Measured at baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Karen K. Miller, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131378
- Sponsor's protocol ID
- 525
- Other IDs
- MGH GCRC 678, 2004-P-000013, R01HL077674
- Status last verified
- Mar 2016
- First submitted
- 16 Aug 2005
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 29679919Bredella 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.
PubMed 28628810Bove 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.
PubMed 26663235Dichtel 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.
PubMed 25210883Bredella 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.
PubMed 24508386Lin 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.
PubMed 23146135Bredella 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.
PubMed 22275471
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
- ClinicalTrials.gov ID
- NCT00131378
- Acronym / sponsor ID
- 525
- Conditions
- Obesity
- Keywords
- Visceral obesity, Growth hormone, Cardiovascular risk, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Aug 2005 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male on GH | Experimental | Drug: Nutropin AQ growth hormoneParticipants 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. |
| Male on Placebo | Placebo comparator | Drug: Placebo Growth HormoneParticipants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
| Female on GH | Experimental | Drug: Nutropin AQ growth hormoneParticipants 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. |
| Female on Placebo | Placebo comparator | Drug: Placebo Growth HormoneParticipants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- For growth hormone measurement part (for men and women):
- For growth hormone treatment part (for men and women):
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutropin AQ growth hormoneParticipants will give themselves injections of growth hormone every night for 6 months. | Drug | Female on GH, Male on GH |
| Placebo Growth HormoneParticipants will give themselves injections of placebo growth hormone every night for 6 months. | Drug | Female on Placebo, Male on Placebo |
Primary outcome
HsCRP
Time frame: Measured at baseline and month 6
6 month change in HsCRP (primary cardiovascular risk endpoint)
Total Abdominal Fat
Time frame: Measured at baseline and month 6
6 month change in total abdominal fat (primary body composition endpoint)
Abdominal Fat
Time frame: Measured at baseline and month 6
6 month change in visceral abdominal fat (primary body composition endpoint)
2 secondary outcomes
Measure of Insulin Resistance
Time frame: Measured at baseline and month 6
Insulin-like Growth Factor-1 (IGF-1) Levels
Time frame: Measured at baseline and month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29679919Dichtel 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.
- Derived from this study: PubMed 28628810Bredella 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.
- Derived from this study: PubMed 26663235Bove 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.
- Derived from this study: PubMed 25210883Dichtel 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.
- Derived from this study: PubMed 24508386Bredella 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.
- Derived from this study: PubMed 23146135Lin 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.
- Derived from this study: PubMed 22275471Bredella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen K. Miller, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutropin AQ growth hormone in people with Obesity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HsCRP (time frame: Measured at baseline and month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131378, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.