Insulin Sensitivity & Substrate Metabolism Before & After NCT00646815

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00646815
Other study ID #	LM2008
Secondary ID
Status	Completed
Phase	N/A
First received	February 19, 2008
Last updated	October 21, 2009
Start date	March 2008
Est. completion date	September 2009

Study information
Verified date	October 2009
Source	University of Aarhus
Contact	n/a
Is FDA regulated	No
Health authority	Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type	Interventional

Clinical Trial Summary

The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).

Recruitment information / eligibility
Status	Completed
Enrollment	24
Est. completion date	September 2009
Est. primary completion date	September 2009
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	18 Years to 60 Years
Eligibility	Inclusion Criteria: - Written informed consent - Must be of legal age and competent - Age: >18 and <60 years old - Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study Exclusion Criteria: - Alcohol consumption >21 units per week - Malignant disease - Pregnancy - Magnetic implants or material in the body - Claustrophobia - BMI >30 - Heart disease (NYHA >2) - Uncontrolled hypertension - Manifest diabetes mellitus - Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial. Controls are matched on age, gender and BMI Inclusion Criteria: - Written informed consent - Must be of legal age and competent Exclusion Criteria: - Alcohol consumption >21 units per week - Malignant disease - Pregnancy - Magnetic implants or material in the body - Claustrophobia - Heart disease (NYHA >2) - Uncontrolled hypertension - Manifest diabetes mellitus - Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• growth hormone (genotropin)
Dosage regulation will follow the local recommendations of GHD treatment

Locations
Country	Name	City	State
Denmark	Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.	Aarhus
Denmark	Medical Department M, Aarhus University Hospital	Aarhus

Sponsors *(2)*
Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark,

Outcome
Type	Measure	Time frame	Safety issue
Primary	insulin sensitivity	before and after 3 months treatment with growth hormone	No
Secondary	substrate metabolism	before and after 3 months of growth hormone treatment	No
Secondary	intrahepatic lipid content	before and after 3 months of growth hormone treatment	No
Secondary	intramyocellular lipid content	before and after 3 months of growth hormone treatment	No

See also
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Completed	`NCT00990340` - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method	Phase 4
Completed	`NCT00235599` - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.	N/A
Completed	`NCT00149708` - Consequence of Lifetime Isolated Growth Hormone Deficiency	N/A
Completed	`NCT00459940` - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients	N/A
Completed	`NCT01157793` - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood	Phase 4
Completed	`NCT00004365` - Study of Pituitary Size and Function in Familial Dwarfism of Sindh	N/A
Recruiting	`NCT00227253` - Chromosome 18 Clinical Research Center
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Completed	`NCT02934399` - Dynamic Hormone Diagnostics in Endocrine Disease
Completed	`NCT01090778` - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)	Phase 2
Completed	`NCT00965484` - Genotropin Study Assessing Use of Injection Pen	Phase 3
Completed	`NCT01062529` - Peripheral Metabolic Effects of Somatostatin	N/A
Completed	`NCT00616278` - National Cooperative Growth Study in CKD	N/A
Completed	`NCT02693522` - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency	Phase 3
Recruiting	`NCT02908958` - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency	Phase 4
Terminated	`NCT01243892` - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device	N/A
Withdrawn	`NCT00638287` - Inter-Assay Growth Hormone and IGF-I Variability	N/A
Completed	`NCT00957671` - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury	Phase 4

Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

Outcome

External Links