Effect of Growth Hormone in Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Chinese University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00307411
First received: March 27, 2006
Last updated: April 3, 2006
Last verified: March 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307411

Contacts
Contact: Alice PS Kong, M.B.,Ch.B. 852-2632 3123 kongps@yahoo.com

Locations
China
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    kongps@yahoo.com   
Principal Investigator: Alice PS Kong, M.B.,Ch.B.         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Alice PS Kong, M.B.,Ch.B. Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00307411     History of Changes
Other Study ID Numbers: CUHK 4470/05M
Study First Received: March 27, 2006
Last Updated: April 3, 2006
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Metabolic syndrome

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

ClinicalTrials.gov processed this record on April 17, 2014