Primary outcomeMean· Baseline and 6 months
Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
| Group | Value (mm^2) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | 57 | 2993 |
| Placebo/no Treatment | 799 | 3184 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEffect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
NCTNCT01169103 (opens ClinicalTrials.gov in a new tab)Other id2009P000861
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 22 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Mar 2010
- Primary completion
- Apr 2013
- Completion
- Dec 2014
- First posted
- 23 Jul 2010 (estimated)
- Last update posted
- 2 Nov 2021
- Conditions
- Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012201320142015
- Ph 2
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
NCT01169103Mar 2010 to Dec 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk for diabetes and for heart disease. Overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. In children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. We are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. We hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.
Interventions
- recombinant human growth hormone (rhGH)Drug
- PlaceboDrug
Arms2
Experimental
recombinant human growth hormone
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo comparator
Placebo
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Primary outcomes4
Outcomes the sponsor listed as primary.
Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
Time frame · Baseline and 6 months
Registry description
Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)
Changes in Lipid Panel
Time frame · Baseline and 6 months
Registry description
Lipid 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
Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
Time frame · Baseline and 6 months
Registry description
As 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.
Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months
Time frame · Baseline and 6 months
Registry description
Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk
Secondary outcomes(1)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score
Time frame · Baseline and 6 months
Registry description
Homeostasis 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\]
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline and 6 months
Changes in Lipid Panel
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -37.8 | 23.9 |
| Placebo/no Treatment | -8.6 | 15.5 |
Primary outcomeMean· Baseline and 6 months
Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
| Group | Value (mg/L) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -0.77 | 2.4 |
| Placebo/no Treatment | -0.09 | 1.8 |
Primary outcomeMean· Baseline and 6 months
Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -22.2 | 30.3 |
| Placebo/no Treatment | 21.1 | 33.3 |
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline and 6 months
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score
| Group | Value (HOMA-IR score) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -0.52 | 2.63 |
| Placebo/no Treatment | -2.92 | 8.23 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Recombinant Human Growth HormoneForty 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. | – | 0 / 11 | 10 / 11 |
| Placebo/no TreatmentForty 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. | – | 0 / 11 | 7 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedSlattery M, Bredella MA, Stanley T, Torriani M, Misra M. Effects of recombinant human growth hormone (rhGH) administration on body composition and cardiovascular risk factors in obese adolescent girls. Int J Pediatr Endocrinol. 2014;2014(1):22. doi: 10.1186/1687-9856-2014-22. Epub 2014 Nov 15. PMID 25435886
- DerivedSlattery MJ, Bredella MA, Thakur H, Torriani M, Misra M. Insulin resistance and impaired mitochondrial function in obese adolescent girls. Metab Syndr Relat Disord. 2014 Feb;12(1):56-61. doi: 10.1089/met.2013.0100. Epub 2013 Nov 19. PMID 24251951
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 13 Years up to 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Adolescent girls 13-21 years old with bone age ≥ 14 years
* Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
* Waist/Hip ratio ≥ 0.85
* Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age
Exclusion Criteria:
* Pregnancy (positive pregnancy test) prior to enrollment in the study
* Significant weight gain or loss within 3 months of study (more than 5 kg)
* Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)
* Use of medications such as Meridian and Orlistat
* Presence of diabetes mellitus
* Uncontrolled Thyroid disorders
* Chronic renal insufficiency
* Participation in another simultaneous medical investigation or trial
* Active neoplasm or history of cancer
* Prader-Willi syndrome
* History of scoliosis if bone age is \<15 years
* Hypersensitivity to rhGH or constituents of the injections
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