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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

NCTNCT01421589 (opens ClinicalTrials.gov in a new tab)Other id2011-P-000770
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
15 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2011
Primary completion
Mar 2013
Completion
Mar 2013
First posted
23 Aug 2011 (estimated)
Last update posted
1 Jul 2014 (estimated)
Conditions
Obese · Growth Hormone Secretion Abnormality

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. N/A

    Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

    NCT01421589

    Sept 2011 to Mar 2013

Registry summary

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

Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.

Interventions

  • Growth hormone treatmentDrug

Arms1

  • Experimental

    Growth Hormone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Phosphocreatine Recovery

    Time frame · 12-weeks

    Registry description

    The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.

Secondary outcomes(6)

  1. Change in Circulating IGF-1 Concentration

    Time frame · Baseline and 12-weeks

    Registry description

    Change in circulating IGF-1 from Baseline to 12-weeks is reported.

  2. Change in Skeletal Muscle IGF-1 Gene Expression

    Time frame · Baseline and 12-weeks

    Registry description

    Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.

  3. Change in Body Composition

    Time frame · Baseline and 12-weeks

    Registry description

    Change in waist circumference from Baseline to 12-weeks is reported.

  4. Change in Inflammatory Marker

    Time frame · Baseline and 12-weeks

    Registry description

    Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.

  5. Change in Insulin Sensitivity

    Time frame · Baseline and 12-weeks

    Registry description

    Change in fasting glucose from Baseline to 12-weeks is reported.

  6. Change in Phosphocreatine Recovery

    Time frame · Baseline and 12-weeks

    Registry description

    Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.

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 outcomeNumber· 12-weeks

Phosphocreatine Recovery

GroupValue (correlation coefficient)Spread
Growth Hormone Treatment0.745.4
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline and 12-weeks

Change in Circulating IGF-1 Concentration

GroupValue (ug/l)Spread
Growth Hormone Treatment21829
Secondary outcomeMean· Baseline and 12-weeks

Change in Skeletal Muscle IGF-1 Gene Expression

GroupValue (fold change)Spread
Growth Hormone Treatment2.10.3
Secondary outcomeMean· Baseline and 12-weeks

Change in Body Composition

GroupValue (cm)Spread
Growth Hormone Treatment-31
Secondary outcomeMean· Baseline and 12-weeks

Change in Inflammatory Marker

GroupValue (mg/l)Spread
Growth Hormone Treatment-1.780.57
Secondary outcomeMean· Baseline and 12-weeks

Change in Insulin Sensitivity

GroupValue (mg/dl)Spread
Growth Hormone Treatment63
Secondary outcomeMean· Baseline and 12-weeks

Change in Phosphocreatine Recovery

GroupValue (mM/min)Spread
Growth Hormone-10.27.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Growth Hormone TreatmentGrowth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.–0 / 1511 / 15

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.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men age 18-60 years old 2. BMI ≥ 30 kg/m2 3. Waist circumference ≥ 102 cm 4. Peak GH value of ≤ 4.2 μg/l on standard GHRH-arginine stimulation test Exclusion Criteria: 1. Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of gastric bypass procedure. 2. Subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs. 3. Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants 4. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment. 5. Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening 6. History of pituitary tumor, hypopituitarism, pituitary surgery, pituitary/brain radiation or traumatic brain injury or any other condition known to affect the GH axis. 7. Severe chronic illness including HIV, active malignancy or history of colon cancer. 8. Hemoglobin \< 9.0 g/dL, SGOT \> 2.5 x upper limit normal, Creatinine \>1.5 mg/dL, or PSA \>5 ng/ml. 9. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. 10. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient. 11. Contraindications to MRI scanning.

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