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Trial · Interventional

CompletedNot applicableRegistry data

Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women

Overview

Status
Completed
Phase
Not applicable
Enrollment
63 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jan 2002
Primary completion
Nov 2006
Completion
Nov 2006
First posted
26 Aug 2005 (estimated)
Last update posted
18 Feb 2008 (estimated)
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220032004200520062007
  1. N/A

    Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women

    NCT00136032

    Jan 2002 to Nov 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy: * has effects on women's cardiovascular risk markers (special blood tests which indicate how healthy the heart and arteries are) * has effects on women's types and levels of various substances circulating in their blood * in women affects the stiffness of their arteries and heart rate variability in parallel with changes in cardiovascular risk markers * has different effects depending on whether women are pre or post menopausal. Participation in this study is expected to last approximately 12 months.

Interventions

  • SomatropinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    1

  • Placebo comparator

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Gender specific effects on cardiovascular risk markers

    Time frame · baseline, 1, 3, 6, 7, 9, and 12 months

Secondary outcomes(2)
  1. Heart Rate Variability

    Time frame · baseline, 3, 6, 9, and 12 months

  2. Quality of Life

    Time frame · baseline, 1, 3, 6, 7, 9, and 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies9

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Randomized controlled trial · 1998

18 results

The Australian Multicenter Trial of Growth Hormone (GH) Treatment in GH-Deficient Adults.

Cuneo et al. 1998The Journal of clinical endocrinology and metabolismcited by 154

PMID 9435425DOI 10.1210/jcem.83.1.4482PUB-09435425

Rights unknown18 results

Indexing hint: Randomized controlled trial · 1997

6 results

Growth hormone (GH) replacement reduces total body fat and normalizes insulin sensitivity in GH-deficient adults: a report of one-year clinical experience.

Hwu et al. 1997The Journal of clinical endocrinology and metabolismcited by 71

PMID 9329355DOI 10.1210/jcem.82.10.4311PUB-09329355

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 1996

7 results

Effects of physiologic growth hormone therapy on bone density and body composition in patients with adult-onset growth hormone deficiency. A randomized, placebo-controlled trial.

Baum et al. 1996Annals of internal medicinecited by 160

PMID 8967668DOI 10.7326/0003-4819-125-11-199612010-00003PUB-08967668

Full text at the publisher7 results

Indexing hint: Randomized controlled trial · 1996

4 results

Low-dose growth hormone replacement lowers plasma leptin and fat stores without affecting body mass index in adults with growth hormone deficiency.

Florkowski et al. 1996Clinical endocrinologycited by 54

PMID 9039344DOI 10.1046/j.1365-2265.1996.830895.xPUB-09039344

Full text at the publisher4 results

Indexing hint: Clinical trial · 1995

12 results

The effect of low dose recombinant human growth hormone replacement on regional fat distribution, insulin sensitivity, and cardiovascular risk factors in hypopituitary adults.

Weaver et al. 1995The Journal of clinical endocrinology and metabolismcited by 173

PMID 7829604DOI 10.1210/jcem.80.1.7829604PUB-07829604

Full text at the publisher12 results

Indexing hint: Randomized controlled trial · 1995

25 results

The effects of short and long-term growth hormone replacement therapy in hypopituitary adults on lipid metabolism and carbohydrate tolerance.

Beshyah et al. 1995The Journal of clinical endocrinology and metabolismcited by 99

PMID 7852490DOI 10.1210/jcem.80.2.7852490PUB-07852490

Full text at the publisher25 results

Indexing hint: Randomized controlled trial · 1989

8 results

The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency.

Salomon et al. 1989The New England journal of medicinecited by 770

PMID 2687691DOI 10.1056/nejm198912283212605PUB-02687691

Full text at the publisher8 results

More studies

2 studies on this page

PubMed tag: none · 1999

Growth hormone (GH) treatment reverses early atherosclerotic changes in GH-deficient adults.

Pfeifer et al. 1999The Journal of clinical endocrinology and metabolismcited by 170

PMID 10022400DOI 10.1210/jcem.84.2.5456PUB-10022400

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1999

Decrease in carotid intima-media thickness after one year growth hormone (GH) treatment in adults with GH deficiency.

Borson-Chazot et al. 1999The Journal of clinical endocrinology and metabolismcited by 76

PMID 10199774DOI 10.1210/jcem.84.4.5595PUB-10199774

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * GH deficiency due to pituitary or hypothalamic tumors or disease affecting this area. Subjects will have been treated with medication, surgery, radiation, or a combination of these. GH deficiency will be defined as a peak plasma GH of less than 5 ng/ml in response to insulin tolerance testing or growth hormone releasing hormone (GHRH) plus arginine stimulation test. In subjects with suspected hypothalamic dysfunction the arginine plus L-dopa stimulation test may be used, with a cutoff of 1.7 ng/ml for diagnosis of GH deficiency. Partial GH deficiency will be defined as a GH peak of 5 to 9 ng/ml (inclusive) during insulin tolerance testing or GHRH plus arginine testing. * GH deficiency will also be diagnosed if insulin-like growth factor-I (IGF-I) levels are below 2 standard deviations for the age-sex normal range in a patient with at least two documented hormone deficiencies. * Subjects must have evidence of a stable pituitary mass (for at least 12 months) if there is a history of a tumor except in the case of ACTH-producing microadenomas, where no follow-up imaging is required after cure. * Subjects age 40 and over must have a screening mammogram if they have not already had one within one year prior to their baseline visit Exclusion Criteria: * Active Cushing's disease within 1 year * History of acromegaly * Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study. * History of malignancy except for skin cancer and except for childhood solid malignancy with documented cure for \> 10 years prior to starting the study * Hemoglobin \<10.0 gm/dl * Hepatic or renal disease (SGPT/SGOT \> 3x upper limit of normal (ULN) or creatinine levels \>2.5 mg/dl) * Congestive heart failure (CHF) (New York Heart Association's classification system Class II-IV CHF will be excluded) * History of unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study * Diabetes mellitus * Pregnancy or nursing * Active carpal tunnel syndrome

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