NCT00453557

Brief Summary

Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Apr 1999

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

March 27, 2007

Last Update Submit

December 6, 2016

Conditions

Obesity

Keywords

growth hormone, obesity, visceral adiposity

Outcome Measures

Primary Outcomes (2)

  • body composition at baseline, after 6 months of treatment and at the end of the followup period

  • energy expenditure at baseline, after 6 months of treatment and at the end of the followup period

Secondary Outcomes (1)

  • gene expression in adipose tissue at baseline and after 6 months of treatment

Interventions

rhGHDRUG

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, aged 40-70
  • Central obesity defined as waist circumference greater than 102 cm and BMI \> 27 and \< 35 kg/m2
  • No weight loss in last 12 months
  • Total IGF-1 level \< 241 ng/ml (\~25th percentile for the assay)
  • Body habitus which permitted accurate CT scan acquisition and analysis.

You may not qualify if:

  • Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease
  • Diabetes
  • Known coronary heart disease
  • Exercised more than 3 hours per week
  • Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven R Smith, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Medical Doctor

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

April 1, 1999

Primary Completion

December 1, 2000

Study Completion

December 1, 2000

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

US(1)