- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02084095
IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly
The Role of Insulin-like Growth Factor-I (IGF-I) and Free Fatty Acids in Insulin Resistance, Insulin Secretion and Glucose Metabolism Abnormalities in Acromegaly
Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I) correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS is independent of acromegaly intensity.
The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.
Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test acording to Bergman model. FFA will be directly measured in plasma.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bucharest, Romania, 011863
- "C. I. Parhon" Institute of Endocrinology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- active acromegaly based on following criteria: minimum GH in oral glucose tolerance test (OGTT) over 1 ng/mL and serum IGF-I over upper limit of normal for age and sex
- age between 18 and 65 years old
Exclusion Criteria:
- more than one previous pituitary surgical intervention for acromegaly
- present medical treatment for acromegaly (somatostatin analogs, GH-receptor blockers, dopaminergic agonists)
- previous pituitary radiotherapy
- present medical treatment for hyperglycemia (oral antidiabetic drugs, insulin, etc)
- pituitary failure, treated or not
- medical or surgical conditions which, in the oppinion of the principal investigator, could impact on study results or patient's safety
- fasting blood glucose over 200 mg/dL or HbA1c over 8%.
- body mass index less than 20 or over 35 kg/mp
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The correlation coefficient between IGFBP-3 and insulin resistance assessed using Bergman model is non-inferior to the correlation coefficient between IGF-I and insulin resistance
Time Frame: 2 years
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2 years
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Free fatty acids correlates significantly with insulin resistance assessed using Bergman model
Time Frame: 2 years
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2 years
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Disposition index calculated using Bergman model is significantly reduced in subjects with glucose intolerance than in subjects with normal glucose tolerance
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GH, IGF-I and IGFBP-3 significantly correlates with insulin resistance calculated using Bergman model
Time Frame: 2 years
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2 years
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GH, IGF-I and IGFBP-3 significantly correlates with free fatty acids
Time Frame: 2 years
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2 years
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GH, IGF-I and IGFBP-3 does not correlate with insulin sensitivity calculated using Bergman model
Time Frame: 2 years
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2 years
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GH, IGF-I and IGFBP-3 does not correlate with disposition index
Time Frame: 2 years
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2 years
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Disposition index after reduction of acromegaly activity by various treatments
Time Frame: 3 months after surgery or start of medical treatment
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3 months after surgery or start of medical treatment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28332
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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