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Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00675506
First received: May 7, 2008
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Abdominal Obesity
Growth Hormone Deficiency
Interventions: Drug: Growth hormone releasing hormone (GHRH) 1-44
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TH9507

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months
Placebo

Participants received treatment with placebo medication.

Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participant Flow:   Overall Study
    TH9507     Placebo  
STARTED     31     29  
Received Intervention     29 [1]   29  
COMPLETED     19     17  
NOT COMPLETED     12     12  
Lost to Follow-up                 1                 5  
Lost interest                 3                 5  
Elevated fasting glucose                 2                 1  
Elevated IGF-1 prior to treatment                 1                 0  
Elevated IGF-1                 2                 0  
Hypersensitivity Reaction                 1                 0  
Disclosed history of cancer                 1                 0  
Declined participation                 1                 0  
Schedule conflict                 0                 1  
[1] Two subjects did not start treatment: 1) disclosed cancer history, 2) declined participation.



  Baseline Characteristics
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Reporting Groups
  Description
TH9507

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months
Placebo

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months
Total Total of all reporting groups

Baseline Measures
    TH9507     Placebo     Total  
Number of Participants  
[units: participants]
 		  31     29     60  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     31     29     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.5  ± 7.1     39.9  ± 9.5     41.2  ± 8.4  
Gender  
[units: participants]
 		     
Female     11     10     21  
Male     20     19     39  
Region of Enrollment  
[units: participants]
 		     
United States     31     29     60  



  Outcome Measures
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1.  Primary:   Change in Visceral Adipose Tissue Volume   [ Time Frame: Measured at baseline and Months 6 and 12 ]
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2.  Secondary:   Change in Carotid Intima-media Thickness   [ Time Frame: Measured at baseline and Months 6 and 12 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)   [ Time Frame: Measured at baseline and Months 6 and 12 ]
  Show Outcome Measure 3

4.  Secondary:   Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test   [ Time Frame: Measured at baseline and Months 6 and 12 ]
  Show Outcome Measure 4

5.  Secondary:   Change in Growth Hormone Pulse Characteristics as Assessed by Overnight Frequent Sampling of Growth Hormone   [ Time Frame: Measured at baseline and Month 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Mitochondrial Function by 31P-MRS   [ Time Frame: Measured at Baseline and Months 6 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Steven K. Grinspoon MD
Organization: Massachusetts General Hospital
phone: 617-726-3890
e-mail: sgrinspoon@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00675506     History of Changes
Other Study ID Numbers: 574, 1R01HL085268-01A1, 1R01HL85268-01A1
Study First Received: May 7, 2008
Results First Received: October 23, 2012
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration