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

N/ACompletedNCT02084095

Carol Davila University of Medicine and Pharmacy16 enrolled

Overview

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

Enrollment

Conditions

Acromegaly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Free fatty acids correlates significantly with insulin resistance assessed using Bergman model

Time frame: 2 years

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

Secondary Outcomes

GH, IGF-I and IGFBP-3 significantly correlates with insulin resistance calculated using Bergman model

Time frame: 2 years

GH, IGF-I and IGFBP-3 significantly correlates with free fatty acids

Time frame: 2 years

GH, IGF-I and IGFBP-3 does not correlate with insulin sensitivity calculated using Bergman model

Time frame: 2 years

GH, IGF-I and IGFBP-3 does not correlate with disposition index

Time frame: 2 years

Disposition index after reduction of acromegaly activity by various treatments

Time frame: 3 months after surgery or start of medical treatment

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes