This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effect of Growth Hormone in Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Chinese University of Hong Kong.
Recruitment status was:  Not yet recruiting
Information provided by:
Chinese University of Hong Kong Identifier:
First received: March 27, 2006
Last updated: April 3, 2006
Last verified: March 2006
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 Intervention Phase
Metabolic Syndrome Drug: Growth hormone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

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

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

Estimated Enrollment: 32
Study Start Date: August 2006
Estimated Study Completion Date: July 2007
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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00307411     History of Changes
Other Study ID Numbers: CUHK 4470/05M
Study First Received: March 27, 2006
Last Updated: April 3, 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 processed this record on September 21, 2017