NCT00646815CompletedNot Applicable
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- insulin sensitivity
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
a
Experimental
the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency
Intervention: growth hormone (genotropin) (Drug)
Outcomes
Primary Outcomes
insulin sensitivity
Time Frame: before and after 3 months treatment with growth hormone
Secondary Outcomes
- substrate metabolism(before and after 3 months of growth hormone treatment)
- intrahepatic lipid content(before and after 3 months of growth hormone treatment)
- intramyocellular lipid content(before and after 3 months of growth hormone treatment)
Investigators
Study Sites (2)
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