An observational study in Acromegaly, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by University of Roma La Sapienza · Observational
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.
The observational study will concern the collection of data from patients who, as they are not controlled by SSAs therapy (cohort 1), require PEG therapy in monotherapy (group 1) or in combination with SSAs (group 2), according to common clinical practice. The investigators will enroll also acromegalic patients adequately controlled by medical therapy (cohort 2), respectively treated by any kind of SSAs (group 3) and by PEG (group 4) for comparison between different medical treatments. The data will be prospectively collected at baseline and after 8 weeks of treatment.
A control group will be enrolled including healthy volunteers matched with patients for age and sex.
The primary outcome will be the immune profiling by quantification of peripheral blood mononuclear cells (PBMC) subpopulations.
Secondary outcome measures will be
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 62 is below the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, by any kind of SSAs or by PEG
Healthy volunteers matched with patients for age and sex
Peripheral blood mononuclear cell subpopulations
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Time frame: baseline
Change of peripheral blood mononuclear cell subpopulations
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Time frame: baseline and after 8 weeks
Tumor necrosis factor alfa (TNFα)
Chemiluminescence measurement of TNFα serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Transforming growth factor beta (TGF-β)
Chemiluminescence measurement of TGF-β serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Interleukin-1 (IL-1)
Chemiluminescence measurement of IL-1 serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Interleukin-6 (IL-6)
Chemiluminescence measurement of IL-6 serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Interleukin-10 (IL-10)
Chemiluminescence measurement of IL-10 serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Interferon gamma
Chemiluminescence measurement of interferon gamma serum concentrations (pg/ml)
Time frame: baseline and post 8 weeks
Monocyte chemoattractant protein (MCP-1)
Chemiluminescence measurement of MCP-1 (pg/ml)
Time frame: baseline and post 8 weeks
Adipokines production (visfatin)
Measurement of visfatin serum concentrations
Time frame: baseline and post 8 weeks
Adipokines production (adiponectin)
Measurement of adiponectin serum concentrations
Time frame: baseline and post 8 weeks
Adipokines production (vaspin)
Measurement of vaspin serum concentrations
Time frame: baseline and post 8 weeks
Adipokines production (omentin)
Measurement of omentin serum concentrations
Time frame: baseline and post 8 weeks
Metabolic parameters: glycemia
Evaluation of glucose (mmol/l)
Time frame: baseline and post 8 weeks
Insulin production
Evaluation of insulin (mU/L)
Time frame: baseline and post 8 weeks
Insulin secretion
Evaluation of c-peptide (ng/ml)
Time frame: baseline and post 8 weeks
Metabolic parameters: glycosylated haemoglobin
Evaluation of HbA1c (mmol/mol)
Time frame: baseline and post 8 weeks
Lipid profile: triglycerides
Evaluation of triglycerides (mmol/l)
Time frame: baseline and post 8 weeks
Lipid profile: cholesterol
Evaluation of total cholesterol (mmol/l)
Time frame: baseline and post 8 weeks
Lipid profile: HDL-cholesterol
Evaluation of HDL-cholesterol (mmol/l)
Time frame: baseline and post 8 weeks
Lipid profile: LDL-cholesterol
Evaluation of LDL-cholesterol (mmol/l)
Time frame: baseline and post 8 weeks
Lipid profile: Apo B
Evaluation of apolipoprotein B (mmol/l)
Time frame: baseline and post 8 weeks
Lipid profile: Apo A
Evaluation of apolipoprotein A (mmol/l)
Time frame: baseline and post 8 weeks
Insulin resistance
Evaluation of the homeostasis model assessment for insulin resistance (HOMA-IR) index
Time frame: baseline and post 8 weeks
beta cell function
Evaluation of the homeostasis model assessment for β cell secretion (HOMA-β)
Time frame: baseline and post 8 weeks
Body mass index (BMI)
Body weight and height weight will be combined to report BMI in kg/m\^2
Time frame: baseline and post 8 weeks
Anthropometric parameters
Waist and hip circumference will be combined to report waist-hip ratio
Time frame: baseline and post 8 weeks
Body composition: lean mass
Lean mass distribution (%) evaluated by a whole-body dual-energy x-ray absorptiometry (DEXA) scan
Time frame: baseline and post 8 weeks
Body composition: fat mass
Fat mass distribution (%) evaluated by a whole-body dual-energy x-ray absorptiometry (DEXA) scan
Time frame: baseline and post 8 weeks
Biochemical control
Fasting samples from all patients will be assayed for disease control parameters (insulin-growth factor and growth hormone)
Time frame: baseline and post 8 weeks
Quality of life SF-36-Item Health Survey questionnaire
Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self administered questionnaire SF-36-Item Health Survey questionnaire. This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component). Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state
Time frame: baseline and post 8 weeks
Acromegaly Quality of Life Questionnaire
Evaluation of quality of life by the Acromegaly Quality of Life Questionnaire (ACROQOL), a disease specific questionnaire to measure quality of life in patients with acromegaly. It contains 22 items divided in two scales that measure physical and psychological aspects. Each of the 22 items of the AcroQoL is answered in a 1 to 5. A global score is obtained adding the results of the 22 items using a specific formula, from a minimum of 22 - worse QoL - until 110 - best QoL -
Time frame: baseline and post 8 weeks
Sleep apnea
Sleep disturbances will be measured by Epworth Sleepiness Scale (ESS). The ESS consists of eight questions regarding eight activities. Each of the activities listed has an assigned score from 0 to 3 that indicates how likely a person is to fall asleep during the activity: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing. The total score can range from 0 to 24. A higher score is associated with increased sleepiness.
Time frame: baseline and post 8 weeks
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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