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Completed

NCT Number: NCT02084095

IGF-I and Free Fatty Acids Isn Glucose Metabolism 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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"C. I. Parhon" Institute of Endocrinology

Bucharest, 011863, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 2 years

  3. 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

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

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

  5. Disposition index after reduction of acromegaly activity by various treatments

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

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2014
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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