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

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Deficiency

Intervention: growth hormone (genotropin) (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Jens OL Jorgensen, Professor MD, Principal Investigator, Affiliation: Medical Department M, Aarhus University Hospital, Aarhus, Denmark

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).

Clinical Details

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

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

Primary outcome: insulin sensitivity

Secondary outcome:

substrate metabolism

intrahepatic lipid content

intramyocellular lipid content

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark., Aarhus 8000, Denmark

Medical Department M, Aarhus University Hospital, Aarhus 8000, Denmark

Additional Information

Central Denmark Region Committee on Biomedical Research Ethics

Danish Data Protection Agency

Starting date: March 2008
Last updated: October 21, 2009

Page last updated: August 23, 2015

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