Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

NCT ID: NCT00131378

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2013-06-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutropin AQ growth hormone

Intervention Type: DRUG

Participants will give themselves injections of growth hormone every night for 6 months.

Male on Placebo

Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo Growth Hormone

Intervention Type: DRUG

Participants will give themselves injections of placebo growth hormone every night for 6 months.

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.

Group Type: EXPERIMENTAL

Nutropin AQ growth hormone

Intervention Type: DRUG

Participants will give themselves injections of growth hormone every night for 6 months.

Female on Placebo

Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo Growth Hormone

Intervention Type: DRUG

Participants will give themselves injections of placebo growth hormone every night for 6 months.

Interventions

Nutropin AQ growth hormone

Participants will give themselves injections of growth hormone every night for 6 months.

Intervention Type: DRUG

Placebo Growth Hormone

Participants will give themselves injections of placebo growth hormone every night for 6 months.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen Klahr Miller, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen K. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29679919 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28628810 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26663235 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25210883 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24508386 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23146135 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22275471 (View on PubMed)

Other Identifiers

MGH GCRC 678

Identifier Type: -

Identifier Source: secondary_id

2004-P-000013

Identifier Type: -

Identifier Source: secondary_id

R01HL077674

Identifier Type: NIH

Identifier Source: secondary_id

View Link

525

Identifier Type: -

Identifier Source: org_study_id