Trial Outcomes & Findings for Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls (NCT NCT01169103)
NCT ID: NCT01169103
Last Updated: 2021-11-02
Results Overview
Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-11-02
Participant Flow
Participants were recruited at Massachusetts General Hospital between September 2010 and October 2012 through area pediatric and obesity clinics and advertisements.
Of the 32 subjects who were screened, 22 were eligible \& randomized. 5 subjects were ineligible due to Insulin Like Growth Factor levels above the eligibility limit for pubertal stage or age. 2 were excluded due to planned initiation of medications that were on the exclusion criteria list and 3 voluntarily withdrew consent prior to randomization.
Participant milestones
| Measure |
Recombinant Human Growth Hormone
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Recombinant Human Growth Hormone
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Baseline characteristics by cohort
| Measure |
Recombinant Human Growth Hormone
n=11 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=11 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
16.6 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit.
Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)
Outcome measures
| Measure |
Recombinant Human Growth Hormone
n=5 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=6 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
Change in SAT
|
-111 mm^2
Standard Deviation 6078
|
3634 mm^2
Standard Deviation 5161
|
|
Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
Change in VAT
|
57 mm^2
Standard Deviation 2993
|
799 mm^2
Standard Deviation 3184
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsLipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy
Outcome measures
| Measure |
Recombinant Human Growth Hormone
n=5 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=7 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Changes in Lipid Panel
Change in Total Cholesterol
|
-37.8 mg/dL
Standard Deviation 23.9
|
-8.6 mg/dL
Standard Deviation 15.5
|
|
Changes in Lipid Panel
Change in Triglycerides
|
-27.8 mg/dL
Standard Deviation 46.8
|
6.1 mg/dL
Standard Deviation 58.4
|
|
Changes in Lipid Panel
Change in LDL
|
-25.8 mg/dL
Standard Deviation 12.8
|
-10.7 mg/dL
Standard Deviation 11.9
|
|
Changes in Lipid Panel
Change in HDL
|
-6.6 mg/dL
Standard Deviation 6.1
|
1 mg/dL
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsAs a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.
Outcome measures
| Measure |
Recombinant Human Growth Hormone
n=5 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=7 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
|
-0.77 mg/L
Standard Deviation 2.4
|
-0.09 mg/L
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsSoluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk
Outcome measures
| Measure |
Recombinant Human Growth Hormone
n=5 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=7 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months
|
-22.2 ng/mL
Standard Deviation 30.3
|
21.1 ng/mL
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsHomeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: \[fasting glucose (mmol/l) x fasting insulin (µU/ml)\]/22.5\]
Outcome measures
| Measure |
Recombinant Human Growth Hormone
n=5 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=7 Participants
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score
|
-0.52 HOMA-IR score
Standard Deviation 2.63
|
-2.92 HOMA-IR score
Standard Deviation 8.23
|
Adverse Events
Recombinant Human Growth Hormone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo/no Treatment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recombinant Human Growth Hormone
n=11 participants at risk
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
|
Placebo/no Treatment
n=11 participants at risk
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
|
|---|---|---|
|
Endocrine disorders
Impaired Glucose Tolerance
|
18.2%
2/11
|
36.4%
4/11
|
|
Endocrine disorders
Polyuria/Polydipsia
|
9.1%
1/11
|
27.3%
3/11
|
|
Endocrine disorders
HbA1c > 6.4%
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Headache
|
36.4%
4/11
|
27.3%
3/11
|
|
Gastrointestinal disorders
Nausea with vomiting
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea without vomiting
|
27.3%
3/11
|
0.00%
0/11
|
|
General disorders
Dizziness without Headace
|
0.00%
0/11
|
9.1%
1/11
|
|
Eye disorders
Blurry Vision
|
9.1%
1/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
36.4%
4/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11
|
0.00%
0/11
|
|
Endocrine disorders
Change in Menstrual Flow
|
27.3%
3/11
|
18.2%
2/11
|
|
Endocrine disorders
Fatigue
|
0.00%
0/11
|
18.2%
2/11
|
|
Injury, poisoning and procedural complications
Bruising/Irritation at Injection Site
|
18.2%
2/11
|
18.2%
2/11
|
|
Injury, poisoning and procedural complications
Bruising/Irritation at Blood Sampling Site
|
9.1%
1/11
|
0.00%
0/11
|
|
Cardiac disorders
Hypertension
|
0.00%
0/11
|
9.1%
1/11
|
|
General disorders
ED visit for wheezing with URI
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
2/11
|
0.00%
0/11
|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11
|
0.00%
0/11
|
|
Infections and infestations
Nasal Congestion
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Eczema
|
0.00%
0/11
|
9.1%
1/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place