IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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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

, ,

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

, ,

Verification Date

August 2019