NCT00307411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 4, 2006

Status Verified

March 1, 2006

First QC Date

March 27, 2006

Last Update Submit

April 3, 2006

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in percentage of body fat from baseline.

Secondary Outcomes (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.

Interventions

Growth hormoneDRUG

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Alice PS Kong, M.B.,Ch.B.

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice PS Kong, M.B.,Ch.B.

CONTACT

852-2632 3123kongps@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

August 1, 2006

Study Completion

July 1, 2007

Last Updated

April 4, 2006

Record last verified: 2006-03

Locations

CN(1)