Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518635
Status:
WITHDRAWN
Last Update Posted:
2013-02-20
First Post:
2007-08-17
Brief Title:
Low Dose Growth Hormone in Obese PCOS Women
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys sensitivity to insulin actions and whether this low GH dose can affect the bodys 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
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 bodys sensitivity to insulin actions and whether this low GH dose can affect the bodys 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
Detailed Description:
The study will be a double-blinded cross-over study Thirty subjects will be screened for eligibility initially and the first 12 eligible subjects will be enrolled Six subjects will be randomized to receive the low GH dose 01 mgday treatment and 6 subjects to receive Placebo treatment for 12 weeks exchanging their treatment for a further 12 weeks after a 4-week washout period The study drugs will be stored at the Oregon Health and Science University OHSU Research Pharmacy and following randomization the subjects will be taught by our Endocrine Nurses to self-administer the subcutaneous GH and Placebo injections using NutropinPlacebo vials and insulin syringes into the abdomen at 2200h Randomization for treatment assignment will be performed by an investigator not directly involved in the patients recruitment treatment and follow-up care The randomization process will be performed by computerized pre-assigned random codes by blocks stratified by age and examined for possible differences in body mass index During their in-patient stay at the Oregon Clinical and Translational Research Institute OCTRI at OHSU subjects will only be allowed to eat the food provided to them by the OCTRI
Initial Screening Assessment outpatient
The following assessments will be performed
Written informed consent
Demographics demographic information including the subjects birth date and race
Physical exam and medical history
Previoussignificant medical history
Concomitant medication review
Vital signs eg pulse and blood pressure measurements
Height and weight
Laboratory findings eg CBC electrolytes and fasting glucose levels
Visit 1 Baseline Assessment for the First Treatment Phase in-patient
The following is a description of the assessments that will be performed after consent is obtained
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Randomization to GH or Placebo
Teach GH or Placebo self-administration
Visit 2 Final Assessment for the First Treatment Phase Week 12 - 1 week outpatient
The following is a description of the assessments that will be performed at the end of the first treatment phase with either GH or Placebo Subjects will also be monitored for safety with the collection of the following
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Washout Period and Crossover After the first treatment phase with GH or Placebo the subjects will have a 4-week washout period and the treatment will be crossed over for another 12-week treatment phase with either GH or Placebo During this time the subjects will be advised to maintain a stable diet and weight
Visit 3 Baseline Assessment for the Second Treatment Phase Week 16 - 1 week as outpatient
The following is a description of the assessments that will be performed
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
Treatment exchanged to Placebo or GH
Visit 4 Final Assessment for the Second Treatment Phase Week 28 - 1 week as inpatient
The following is a description of the assessments that will be performed at the end of the second treatment phase with either GH or Placebo Subjects will also be monitored for safety with the collection of the following
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Because of the potentially long duration of Visits 1 2 and 4 the studies can either be divided into two separate admissions upon prior arrangement or can be done all at once with one admission depending on the subjects wishes and schedule
Initial Screening Assessment outpatient
The following assessments will be performed
Written informed consent
Demographics demographic information including the subjects birth date and race
Physical exam and medical history
Previoussignificant medical history
Concomitant medication review
Vital signs eg pulse and blood pressure measurements
Height and weight
Laboratory findings eg CBC electrolytes and fasting glucose levels
Visit 1 Baseline Assessment for the First Treatment Phase in-patient
The following is a description of the assessments that will be performed after consent is obtained
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Randomization to GH or Placebo
Teach GH or Placebo self-administration
Visit 2 Final Assessment for the First Treatment Phase Week 12 - 1 week outpatient
The following is a description of the assessments that will be performed at the end of the first treatment phase with either GH or Placebo Subjects will also be monitored for safety with the collection of the following
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Washout Period and Crossover After the first treatment phase with GH or Placebo the subjects will have a 4-week washout period and the treatment will be crossed over for another 12-week treatment phase with either GH or Placebo During this time the subjects will be advised to maintain a stable diet and weight
Visit 3 Baseline Assessment for the Second Treatment Phase Week 16 - 1 week as outpatient
The following is a description of the assessments that will be performed
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
Treatment exchanged to Placebo or GH
Visit 4 Final Assessment for the Second Treatment Phase Week 28 - 1 week as inpatient
The following is a description of the assessments that will be performed at the end of the second treatment phase with either GH or Placebo Subjects will also be monitored for safety with the collection of the following
Physical exam and medical history
Vital signs eg pulse and blood pressure measurements
Height and weight
Waist circumference measurement
Concomitant medication review
Adverse event recording
Urine pregnancy test
Fasting blood assessments eg hemoglobin glucose insulin C-peptide serum total and free IGF-I IGFBP-3 C-reactive protein adiponectin ghrelin non-esterified fatty acids NEFAs testosterone albumin sex hormone binding globulin and androstenedione
A 3-hour one-step hyperinsulinemic euglycemic clamp
MRS and DEXA scans
Cortisol clearance rate assessments
Fat biopsy
Because of the potentially long duration of Visits 1 2 and 4 the studies can either be divided into two separate admissions upon prior arrangement or can be done all at once with one admission depending on the subjects wishes and schedule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None