NCT00131378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 6, 2014

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

8 years

First QC Date

August 16, 2005

Results QC Date

August 19, 2013

Last Update Submit

March 9, 2016

Conditions

Obesity

Keywords

Visceral obesityGrowth hormoneCardiovascular riskInsulin resistance

Outcome Measures

Primary Outcomes (3)

  • HsCRP

    6 month change in HsCRP (primary cardiovascular risk endpoint)

    Measured at baseline and month 6

  • Total Abdominal Fat

    6 month change in total abdominal fat (primary body composition endpoint)

    Measured at baseline and month 6

  • Abdominal Fat

    6 month change in visceral abdominal fat (primary body composition endpoint)

    Measured at baseline and month 6

Secondary Outcomes (2)

  • Measure of Insulin Resistance

    Measured at baseline and month 6

  • Insulin-like Growth Factor-1 (IGF-1) Levels

    Measured at baseline and month 6

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo Growth Hormone

Interventions

Nutropin AQ growth hormoneDRUG

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

Female on GHMale on GH
Placebo Growth HormoneDRUG

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

Female on PlaceboMale on Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

  • 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.

    PMID: 29679919DERIVED

  • 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.

    PMID: 28628810DERIVED

  • 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.

    PMID: 26663235DERIVED

  • 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.

    PMID: 25210883DERIVED

  • 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.

    PMID: 24508386DERIVED

  • 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.

    PMID: 23146135DERIVED

  • 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.

    PMID: 22275471DERIVED

MeSH Terms

Conditions

ObesityObesity, AbdominalInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Results Point of Contact

Title
Dr. Karen K. Miller
Organization
Massachusetts General Hospital
kkmiller@partners.org
617-726-3870

Study Officials

  • Karen K. Miller, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2012

Study Completion

June 1, 2013

Last Updated

March 11, 2016

Results First Posted

March 6, 2014

Record last verified: 2016-03

Locations

US(1)