Adipose Tissue and Serum Inflammation in GH Deficiency

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Brief Title

Adipose Tissue and Serum Inflammation in GH Deficiency

Official Title

Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency

Brief Summary

      This study will examine adipose tissue inflammation and adipokine expression and serum
      markers of inflammation and adipokine levels in patients with growth hormone (GH) deficiency
      before and after treatment.
    

Detailed Description

      The GH axis has important influences on adipose tissue. Preliminary data from the
      investigators' study in acromegaly, a state of GH excess, suggests that GH reduces adipose
      tissue (AT) mass and serum inflammation. However, GH seems to reduce macrophage markers in
      adipose tissue yet increase adipocyte inflammation. This novel dissociation of macrophage and
      adipocyte inflammation is hypothesized to be due to GH. In order to examine this hypothesis
      further this study will examine adipose tissue and serum inflammation in patients with GH
      deficiency before and after GH therapy. The investigators will obtain subcutaneous adipose
      tissue by biopsy in patients with active GH deficiency planning to undergo therapy for GH
      deficiency. Concurrently serum samples will be taken for analysis of levels of inflammatory
      markers and adipokines. After treatment for 12 months with a normal levels of Insulin-like
      growth factor 1 (IGF-1), a marker of GH deficiency, patients will have a repeat adipose
      tissue biopsy. Adipose tissue parameters will be analyzed in each specimen and then compared
      to each patient over time as well as to body mass index (BMI)-matched control subjects.
    


Study Type

Observational


Primary Outcome

Visceral Adipose Tissue (VAT) mass

Secondary Outcome

 Intra-hepatic lipid level

Condition

Growth Hormone Deficiency

Intervention

Growth Hormone

Study Arms / Comparison Groups

 Adults with growth hormone deficiency
Description:  Subjects who present to the neuroendocrine unit at Columbia University Irving Medical Center (CUIMC) for therapy of GH deficiency or who are followed in the unit and have active GH deficiency and are planning to initiate a therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

May 19, 2019

Completion Date

April 2022

Primary Completion Date

April 2022

Eligibility Criteria

        Inclusion criteria:

          1. Males or females age ≥18 years with diagnosis of GH deficiency that is Adult Onset,
             either alone or associated with multiple pituitary hormone deficiencies and due to
             pituitary disease,hypothalamic disease, surgery, radiation therapy or Childhood Onset
             due to congenital, genetic, acquired, or idiopathic causes.

          2. Diagnosis of GH deficiency defined by: insulin tolerance test or glucagon test: peak
             growth hormone response < 3 ng/ml or 3 or more pituitary hormone deficiencies and
             IGF-1 standard deviation score < -2.0

          3. No history of diabetes mellitus and fasting blood sugar at screening visit ≤ 120
             mg/dl.

          4. If patients have undergone surgical resection of a pituitary adenoma, a minimum of 12
             months must have elapsed post surgery prior to enrollment and tumor will be
             demonstrated to be unchanged for 12 months or longer since surgery.

          5. May have a history of radiotherapy, but they must have completed their course of
             radiotherapy more than 3 months prior to study screening.

          6. If prior GH therapy must have not received prior growth hormone replacement therapy in
             310 the 6 months prior to screening.

          7. Stable pituitary hormone supplements (x 3 months) prior to baseline visit and normal
             levels of free thyroxine, testosterone in males and normal adrenal function if not on
             replacement therapy.

          8. If female, a. Not pregnant (as evidenced by a negative serum pregnancy test) or
             lactating and b. If of childbearing potential, agrees to use a medically acceptable
             form of contraception (such as oral, implantable, or barrier contraception) from the
             time of screening, for the duration of the study, and for at least one month after
             study discontinuation or completion. Childbearing potential is defined as women who
             are not surgically sterile or not at least one year postmenopausal.

          9. Sign and date an informed consent document indicating that the subject (or legally
             acceptable representative) has been informed of and agrees to all pertinent aspects of
             the trial.

        Exclusion Criteria:

          1. Have other conditions that may result in abnormal GH and/or IGF-I concentrations
             (e.g., severe hepatic disease, severe renal disease, malnutrition, treatment with
             levodopa).

          2. Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≥ 2 x upper limit of
             normal or clinically significant hepatic disease or renal impairment defined as
             creatinine > 1.5x upper normal.

          3. Have a pituitary adenoma with a distance to the optic chiasm of 5 mm or less,
             confirmed by a recent MRI scan (within two months prior to the screening visit).

          4. Pituitary tumor growth within the 12 months prior to study entry.

          5. GH therapy within 6 months of screening.

          6. Diabetes mellitus.

          7. History of acromegaly.

          8. History of active Cushing's disease within 24 months of screening

          9. Visual field defects or other neurological symptoms due to current tumor mass
             compression.

         10. Have known or suspected drug or alcohol abuse.

         11. Have received an investigational medication within four weeks prior to Screening or is
             scheduled to receive any investigational medication during the study.

         12. Do not have the ability to fully comprehend the nature of the study, to follow
             instructions, cooperate with study procedures, and/or are unable to adhere to the
             visit scheduled outlined in the protocol.

         13. Have other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration or may interfere with the interpretation of study results and, in
             the judgment of the investigator, would make the subject inappropriate for entry into
             this study.

         14. History of a malignancy other than squamous or basal cell skin carcinoma that has been
             excised or intracranial malignant tumors or leukemia within 5 years of screening.

         15. Patients who have a known hypersensitivity to growth hormone therapy

         16. Use of weight 349 loss medications

         17. Females who plan to change estrogen therapy during the trial

         18. Patients who have received supraphysiologic doses of glucocorticoids within the past 6
             months (except for peri-operative (< 3 days duration) of dexamethasone), or who are
             currently receiving any chemotherapeutic agents.

         19. Patients who have received other investigational drugs administered or received within
             30 days of study entry
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Pamela U. Freda, MD, 212-305-4921, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03500913

Organization ID

AAAP3950

Secondary IDs

1R01DK110771-01A1

Responsible Party

Principal Investigator

Study Sponsor

Columbia University

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Pamela U. Freda, MD, Principal Investigator, Columbia University


Verification Date

July 2021