Brief Title
IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly
Official Title
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
Brief Summary
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 Type
Observational
Primary Outcome
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
Secondary Outcome
GH, IGF-I and IGFBP-3 significantly correlates with insulin resistance calculated using Bergman model
Condition
Acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
16
Start Date
March 2014
Completion Date
March 1, 2019
Primary Completion Date
March 1, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Romania
Location Countries
Romania
Administrative Informations
NCT ID
NCT02084095
Organization ID
28332
Responsible Party
Principal Investigator
Study Sponsor
Carol Davila University of Medicine and Pharmacy
Study Sponsor
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Verification Date
August 2019