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Low Dose Growth Hormone in Obese PCOS Women

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Kevin Yuen, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00518635
First received: August 17, 2007
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

Study hypothesis:

Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of women with polycystic ovary syndrome.

Study aims:

To determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and testosterone (male hormones) in obese women with polycystic ovary syndrome.

Study design:

Obese women with polycystic ovary syndrome, but not recently been on GH treatment, and presently attending Outpatients Clinic will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participating in the study. If suitable, an equal number of women will be randomized to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.


Condition Intervention
Polycystic Ovary Syndrome
 Drug: Nutropin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signaling, Intramyocellular Lipids, and Cortisol Metabolism in Obese Women With Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Growth hormone or Placebo 0.1 mg/day self-administrated once a day.
 Drug: Nutropin
Nutropin 0.1 mg/day self-administered once a day
Other Name: Growth hormone, PCOS, insulin sensitivity

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age 21 to 45 years
  • Body mass index between 30 to 40 kg/m2
  • Diagnosis of PCOS with underlying insulin resistance (assessed by HOMA at screening visit) and/or other features that characterizes the metabolic syndrome such as hypertension ( > 130/85 mmHg), abdominal obesity (waist circumference > 88 cm), and acanthosis nigricans
  • Diagnosis of normal or impaired glucose tolerance (WHO criteria)
  • Stable body weight for at least 6 months prior to study entry (body weight deviating +/- 5 kg from previously recorded weight > 6 months ago)
  • Normal thyroid, renal and hepatic function
  • Able to self administer daily GH/Placebo injections

Exclusion Criteria:

  • Inability to comply with study requirements
  • Body mass index < 30 kg/m2 and > 40 kg/m2 (patients with body mass index > 40 kg/m2 are excluded because they will not fit into the MRS scanner)
  • Untreated hypothyroidism or hyperthyroidism
  • Anemia from any cause
  • Known diabetes mellitus
  • Patients with an increased risk of venous thrombosis or previous history of recurrent venous thrombosis
  • Patient on any insulin-sensitizers (e.g., Metformin, Rosiglitazone, Pioglitazone) within 30 days of screening assessment
  • Patient on any anti-androgens (e.g., Spironolactone, Cyproterone acetate, Flutamide, Finasteride) within 30 days of screening assessment
  • Patient with other concurrent illnesses
  • Pregnant (positive pregnancy test) prior enrollment in the study or planning to conceive whilst participating in the study
  • Emotional/social instability likely to prejudice study completion
  • Previous history of known malignancy
  • Recurrent or severe unexplained hypoglycemia
  • Known or suspected drug/alcohol abuse
  • Patient with any metals in the body
  • Any other condition/s that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518635

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kevin C. Yuen, MRCP(UK), MD Oregon Health and Science University
Principal Investigator: David M. Cook, MD Oregon Health and Science University
  More Information

Additional Information:
Information for women about polycystic ovary syndrome from the American Academy of Family Physicians.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Kevin Yuen, Associate Professor in Endocrinology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00518635     History of Changes
Other Study ID Numbers: IRB3711
Study First Received: August 17, 2007
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Growth hormone
Insulin sensitivity
Polycystic ovary

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Insulin Resistance
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Insulin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013