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Trial record 18 of 21 for:    Tesamorelin OR Egrifta[TREATMENT] AND HIV [CONDITION]

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

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ClinicalTrials.gov Identifier: NCT00675506
Recruitment Status : Completed
First Posted : May 9, 2008
Results First Posted : January 7, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Total Total of all reporting groups

Baseline Measures
   TH9507   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   29   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31 100.0%      29 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (7.1)   39.9  (9.5)   41.2  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  35.5%      10  34.5%      21  35.0% 
Male      20  64.5%      19  65.5%      39  65.0% 
Region of Enrollment 
[Units: Participants]
     
United States   31   29   60 


  Outcome Measures

1.  Primary:   Change in Visceral Adipose Tissue Volume   [ Time Frame: Measured at baseline and Months 6 and 12 ]

2.  Secondary:   Change in Carotid Intima-media Thickness   [ Time Frame: Measured at baseline and Months 6 and 12 ]

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 ]

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

5.  Secondary:   Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone   [ Time Frame: Measured at baseline and Month 12 ]

6.  Secondary:   Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS   [ Time Frame: Measured at Baseline and Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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.


Results Point of Contact:  
Name/Title: Steven K. Grinspoon MD
Organization: Massachusetts General Hospital
phone: 617-726-3890
e-mail: sgrinspoon@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00675506     History of Changes
Other Study ID Numbers: 574
1R01HL085268-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2008
First Posted: May 9, 2008
Results First Submitted: October 23, 2012
Results First Posted: January 7, 2013
Last Update Posted: December 13, 2017