Effect of Growth Hormone in Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307411
Recruitment Status : Unknown
Verified March 2006 by Chinese University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2006
Last Update Posted : April 4, 2006
Information provided by:
Chinese University of Hong Kong

Brief Summary:
Investigating the effect of low dose growth hormone therapy on body fat composition, insulin sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low insulin-like growth factor (IGF-1) level.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Growth hormone Phase 4

Detailed Description:

Metabolic syndrome, a constellation of glucose intolerance, hypertension, dyslipidemia, obesity, pro-inflammatory and prothrombotic state culminating to development of premature cardiovascular diseases is a serious public health problem with significant impact on life expectancy, societal productivity and quality of life of those afflicted with it. Insulin resistance has been proposed as the key linking factor for the metabolic syndrome. Although the underlying mechanism for the development of insulin resistance, diabetes and metabolic syndrome is not fully understood, increasing evidence suggests that neurohormonal dysregulation plays a pivotal role in causing this growing health hazard. In our previous study of 307 middle-aged men, low insulin-like growth factor (IGF)-1 level was independently associated with insulin resistance and metabolic syndrome, especially amongst those with positive family history of diabetes. Replacement with growth hormone has been shown by other researchers to reduce body fat and improve metabolic profiles in patients with adult growth hormone deficiency and type 2 diabetes.

We hypothesize that treatment with growth hormone can lead to reduction of body fat, insulin resistance and cardiovascular risk factors in men with metabolic syndrome. This will be a 12-month prospective, randomized, double-blind, placebo-controlled study using growth hormone treatment in middle-aged men with metabolic syndrome. The primary outcome measure will be body fat distribution, including changes in visceral and mesenteric fat, whereas secondary outcome measure will be insulin sensitivity, and tertiary outcome will be variable parameters of metabolic syndrome.

The results of this study will have important impact on the treatment of patients with metabolic syndrome, and our understanding of the role of growth hormone in the pathogenesis of insulin resistance, diabetes and metabolic syndrome.

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Growth Hormone on Body Fat Distribution, Insulin Action and Cardiovascular Risk Factors in Middle-Aged Men With Metabolic Syndrome
Study Start Date : August 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Somatropin
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in percentage of body fat from baseline.

Secondary Outcome Measures :
  1. Examine the percentage change from baseline in insulin sensitivity, various indices of metabolic syndrome of growth hormone treatment will be compared to placebo arm.

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 35 to 50 Chinese men
  • Metabolic syndrome as defined according to 1998 World Health Organisation with modification using Asian definition for obesity (body mass index 25kg/m2, waist circumference 80cm in women and 90 cm in men)
  • Low IGF-1 level or IGF-1 level in low normal range (<200 ug/L)

Exclusion Criteria:

  • Any malignancy within the past 5 years
  • A diagnosis of acromegaly
  • Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure>105mmHg)
  • A history of carpel tunnel syndrome
  • Poor glycemic control (HbA1c>8%)
  • Diabetic microangiopathy
  • Previous cardiovascular event
  • Anaemia as defined as haemoglobin <11g/dL
  • Active thyroid diseases
  • Any medical illness that will render the subject vulnerable to fluid retention state, e.g. renal impairment, heart failure or as judged by the investigators as ineligible to participate the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307411

Contact: Alice PS Kong, M.B.,Ch.B. 852-2632 3123

Prince of Wales Hospital, The Chinese University of Hong Kong Not yet recruiting
Hong Kong SAR, China
Contact: Alice PS Kong, M.B.,Ch.B.    852-2632 3123   
Principal Investigator: Alice PS Kong, M.B.,Ch.B.         
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Alice PS Kong, M.B.,Ch.B. Chinese University of Hong Kong Identifier: NCT00307411     History of Changes
Other Study ID Numbers: CUHK 4470/05M
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: April 4, 2006
Last Verified: March 2006

Keywords provided by Chinese University of Hong Kong:
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs