NCT05069324

Brief Summary

This is a prospective observational pilot study for the evaluation of immune cells phenotype in acromegalic patients in comparison with a control population and to investigate the impact of disease control and different medical treatments (particularly Pegvisomant) on immune function and its implication on insulin resistance, metabolic complications and fat accumulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

4.4 years

First QC Date

October 19, 2020

Last Update Submit

January 14, 2025

Conditions

Acromegaly

Keywords

AcromegalyPegvisomantImmunityImmune functionMetabolismBody compositionQuality of lifeSleep disturbances

Outcome Measures

Primary Outcomes (2)

  • Peripheral blood mononuclear cell subpopulations

    Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations

    baseline

  • Change of peripheral blood mononuclear cell subpopulations

    Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations

    baseline and after 8 weeks

Secondary Outcomes (31)

  • Tumor necrosis factor alfa (TNFα)

    baseline and post 8 weeks

  • Transforming growth factor beta (TGF-β)

    baseline and post 8 weeks

  • Interleukin-1 (IL-1)

    baseline and post 8 weeks

  • Interleukin-6 (IL-6)

    baseline and post 8 weeks

  • Interleukin-10 (IL-10)

    baseline and post 8 weeks

  • +26 more secondary outcomes

Study Arms (3)

Acromegaly patients not adequately controlled by any kind of SSAs monotherapy

Acromegaly patients not adequately controlled by any kind of SSAs monotherapy, requiring PEG in combination with SSAs or PEG monotherapy

Acromegaly patients adequately controlled by medical treatment

Acromegaly patients adequately controlled by medical treatment, by any kind of SSAs or by PEG

Healthy controls

Healthy volunteers matched with patients for age and sex

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

10 patients with acromegaly not well controlled by SSAs therapy (cohort 1), requiring add PEG to SSAs or switch to PEG monotherapy, according to common clinical practice. 20 patients adequately controlled by medical therapy (cohort 2), treated by any kind of SSAs or by PEG . 30 age- and sex matched controls.

You may qualify if:

  • Previously diagnosed acromegaly not adequately controlled by surgery and/or radiation therapy and in whom an appropriate medical treatment with any kind of somatostatin analogs (SSAs) did not control the disease or was not tolerated;
  • Previously diagnosed acromegaly adequately controlled by medical treatment;
  • Signed informed consent to participate in the study.

You may not qualify if:

  • Adequately controlled disease by surgery and/or radiation;
  • Patients with transaminases more than 3 times the upper limit of normal;
  • Hypersensitivity to PEG or any of its ingredients;
  • History of other neoplasms, radiotherapy or chemotherapy in the last 5 years;
  • Clinical or laboratory signs of significant hepatobiliary, or pancreatic disease;
  • Severe infections, surgery, trauma requiring hospitalization within 3 months before enrolment;
  • Severe chronic kidney disease (stage 4-5);
  • Any active blood or rheumatic disorders in the last 5 years;
  • Pregnant or nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Experimental Medicine, "Sapienza" University of Rome

Rome, 00161, Italy

Location

MeSH Terms

Conditions

AcromegalyParasomnias

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesSleep Wake DisordersMental Disorders

Study Officials

  • Andrea M Isidori, PHD

    Department of Experimental Medicine, "Sapienza" University of Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 6, 2021

Study Start

July 29, 2020

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

IT(1)