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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00675506 (opens ClinicalTrials.gov in a new tab)Other id574Other id1R01HL085268-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
60 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jul 2008
Primary completion
Jan 2012
Completion
Jan 2012
First posted
9 May 2008 (estimated)
Last update posted
13 Dec 2017
Conditions
Abdominal Obesity · Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 2

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

    NCT00675506

    Jul 2008 to Jan 2012

Registry summary

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

Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is also associated with low levels of growth hormone, a hormone that affects rate of growth and the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that makes the body naturally increase its own growth hormone levels. Administering GHRH to people who are obese may help return their growth hormone levels to normal and, in turn, may lead to reduced abdominal fat and improved cardiovascular function. This study will evaluate the effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving cardiovascular function in people who are obese.

Interventions

  • Growth hormone releasing hormone (GHRH) 1-44Drug
  • PlaceboDrug

Arms2

  • Experimental

    1

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

  • Placebo comparator

    2

    Participants will receive treatment with placebo medication.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Visceral Adipose Tissue Volume

    Time frame · Measured at baseline and Months 6 and 12

    Registry description

    Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.

Secondary outcomes(5)

  1. Change in Carotid Intima-media Thickness

    Time frame · Measured at baseline and Months 6 and 12

    Registry description

    Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.

  2. 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

    Registry description

    Lipid Profile (total cholesterol, high-density lipoproteins \[HDL\] cholesterol, low-density lipoproteins \[LDL\] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.

  3. Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test

    Time frame · Measured at baseline and Months 6 and 12

    Registry description

    Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.

  4. 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

    Registry description

    Overnight frequent sampling of growth hormone levels was performed and characteristics of pulsatile secretion were determine using automated deconvolution (using AutoDecon software). Based on the deconvolution, the median pulse mass (in nanograms per millileter of growth hormone) was calculated. A positive number indicates an increase in median pulse mass between baseline and 12 months.

  5. Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS

    Time frame · Measured at Baseline and Month 12

    Registry description

    Change in post-exercise phosphocreatine recovery \[ViPCr\] between baseline and 12 months (positive change indicates increase in the variable between baseline and 12 months). ViPCR is the initial rate of phosphocreatine recovery normalized based on participant effort. Greater ViPCr represents relatively better mitochondrial function.

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· Measured at baseline and Months 6 and 12

Change in Visceral Adipose Tissue Volume

GroupValue (cm2)Spread
TH9507-169
Placebo199
Secondary and other outcome results(5)
Secondary outcomeMean· Measured at baseline and Months 6 and 12

Change in Carotid Intima-media Thickness

GroupValue (mm)Spread
TH9507-0.030.01
Placebo0.010.01
Secondary outcomeMean· Measured at baseline and Months 6 and 12

Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)

GroupValue (mg/dL)Spread
TH950744
Placebo75
Secondary outcomeMean· Measured at baseline and Months 6 and 12

Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test

GroupValue (mg/dL)Spread
TH950723
Placebo12
Secondary outcomeMean· Measured at baseline and Month 12

Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone

GroupValue (nanograms/milliliter)Spread
TH95070.541.35
Placebo0.200.30
Secondary outcomeMean· Measured at Baseline and Month 12

Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS

GroupValue (milliMoles/second)Spread
TH95070.0111.3
Placebo-1.025.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TH9507Participants 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–0 / 3128 / 31
PlaceboParticipants received treatment with placebo medication. Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months–0 / 2926 / 29

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

4 results

The effects of tesamorelin on phosphocreatine recovery in obese subjects with reduced GH.

Makimura et al. 2014The Journal of clinical endocrinology and metabolismcited by 9

PMID 24178787PMC3879673DOI 10.1210/jc.2013-3436PUB-24178787

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2012

11 results

Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial.

Makimura et al. 2012The Journal of clinical endocrinology and metabolismcited by 40

PMID 23015655PMC3513535DOI 10.1210/jc.2012-2794PUB-23015655

Rights unknown11 results
Source linkSee results (11)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedStanley TL, Feldpausch MN, Murphy CA, Grinspoon SK, Makimura H. Discordance of IGF-1 and GH stimulation testing for altered GH secretion in obesity. Growth Horm IGF Res. 2014 Feb;24(1):10-5. doi: 10.1016/j.ghir.2013.11.001. Epub 2013 Nov 15. PMID 24291224

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Body mass index (BMI) greater than or equal to 30 kg/m2 * Waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women * Relative growth hormone (GH) deficiency, defined as a peak GH value of less than or equal to 8 ng/mL on Arginine-GHRH stimulation test * Hemoglobin level greater than 12.0 g/dL * Serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase less than 2.5 times the upper limit of normal * Creatinine level less than 1.5 mg/dL * Follicle stimulating hormone less than 20 IU/L in women * Negative mammogram within 1 year of study entry for women older than 40 years of age Exclusion Criteria: * Obesity due to a known secondary cause (e.g., Cushing's syndrome, hypothyroidism) or a history of gastric bypass procedure * Known hypersensitivity to GHRH 1-44 (TH9507) * Known history of diabetes, fasting blood sugar less than 125 mg/dL, or antidiabetic drug use * Using any weight lowering drugs * Using estrogen, hormone replacement therapy, oral contraceptives, testosterone, glucocorticoids, anabolic steroids, GHRH, GH, or insulin-like growth factor-1 (IGF-1) within 3 months of study entry * Changes in lipid lowering or antihypertensive regimen within 3 months of study entry * Long-term illness, including anemia, chronic kidney disease, and liver disease * History of cancer (except patients with surgically cured basal cell or squamous cell skin cancers) or history of abnormalities on age appropriate malignancy screen, including mammography, colonoscopy, and prostate exam (or prostate specific antigen greater than 5 ng/mL) * History of hypopituitarism, pituitary surgery, pituitary/brain radiation, traumatic brain injury, or any other condition known to affect the growth hormone axis * History of any recent cardiovascular event, including heart attack, stroke, transient ischemic attack, unstable angina pectoris, or oxygen-dependent severe pulmonary disease, within 3 months of study entry * Clinical depression or other psychiatric illness that will not allow completion of the study as per investigator's judgement * History of or current eating disorder * History of recent alcohol or substance abuse (less than 1 year before study entry) * Positive pregnancy test or breastfeeding females and positive fecal occult blood test * Women of childbearing potential not currently using nonhormonal birth control methods, including barrier methods (e.g., IUD, condoms, diaphragms) or abstinence * Currently enrolled in another investigational device or drug trial(s) or has received other investigational agent(s) within 28 days of study entry * Any condition that would make this clinical trial detrimental to the patient, as judged by the patient's physician * History of noncompliance with other therapies * Any condition in which compliance with the study protocol is unlikely

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