AcromegalyNCT05069324
PegvisOMant and the Immune SystEm (PROMISE)
An observational study of Acromegaly, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2020to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- Severe chronic kidney disease (stage 4-5);
- Any active blood or rheumatic disorders in the last 5 years;
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Experimental Medicine, "Sapienza" University of Rome
Rome, 00161
About this study
Official title: The PrOMISE Study: PegvisOMant and the Immune SystEm
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.
Read the detailed description
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
- Evaluation of inflammatory cytokines and adipokines production.
- Evaluation of glucose, insulin, c-peptide, HbA1c, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol apolipoprotein B and A. Insulin resistance and β cell function will be assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) index and for β cell secretion (HOMA-β). Anthropometric measurements will include body weight, height and waist and hip circumference.
- Evaluation of body composition. Composite outcome measure consisting of lean mass, skeletal muscle and fat distribution analysis.
- Fasting samples from all patients will be assayed for disease control parameters.
- Evaluation of quality of life. Quality of life will be measured by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical component summary score and SF-36-Item Health Survey mental component summary score and Acromegaly quality of life (AcroQol) questionnaire.
- Evaluation of sleep disturbances. Sleep disturbances will be measured by Epworth Sleepiness Scale (ESS) and by polysomnography when appropriate.
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Pegvisomant, Immunity, Immune function, Metabolism, Body composition, Quality of life, Sleep disturbances
- Medical subject headings
- Acromegaly, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood mononuclear cell subpopulations
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Measured: baseline
Change of peripheral blood mononuclear cell subpopulations
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Measured: baseline and after 8 weeks
Secondary outcomes (31)
Tumor necrosis factor alfa (TNFα)
Chemiluminescence measurement of TNFα serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Transforming growth factor beta (TGF-β)
Chemiluminescence measurement of TGF-β serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Interleukin-1 (IL-1)
Chemiluminescence measurement of IL-1 serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Interleukin-6 (IL-6)
Chemiluminescence measurement of IL-6 serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Interleukin-10 (IL-10)
Chemiluminescence measurement of IL-10 serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Interferon gamma
Chemiluminescence measurement of interferon gamma serum concentrations (pg/ml)
Measured: baseline and post 8 weeks
Monocyte chemoattractant protein (MCP-1)
Chemiluminescence measurement of MCP-1 (pg/ml)
Measured: baseline and post 8 weeks
Adipokines production (visfatin)
Measurement of visfatin serum concentrations
Measured: baseline and post 8 weeks
Adipokines production (adiponectin)
Measurement of adiponectin serum concentrations
Measured: baseline and post 8 weeks
Adipokines production (vaspin)
Measurement of vaspin serum concentrations
Measured: baseline and post 8 weeks
Adipokines production (omentin)
Measurement of omentin serum concentrations
Measured: baseline and post 8 weeks
Metabolic parameters: glycemia
Evaluation of glucose (mmol/l)
Measured: baseline and post 8 weeks
Insulin production
Evaluation of insulin (mU/L)
Measured: baseline and post 8 weeks
Insulin secretion
Evaluation of c-peptide (ng/ml)
Measured: baseline and post 8 weeks
Metabolic parameters: glycosylated haemoglobin
Evaluation of HbA1c (mmol/mol)
Measured: baseline and post 8 weeks
Lipid profile: triglycerides
Evaluation of triglycerides (mmol/l)
Measured: baseline and post 8 weeks
Lipid profile: cholesterol
Evaluation of total cholesterol (mmol/l)
Measured: baseline and post 8 weeks
Lipid profile: HDL-cholesterol
Evaluation of HDL-cholesterol (mmol/l)
Measured: baseline and post 8 weeks
Lipid profile: LDL-cholesterol
Evaluation of LDL-cholesterol (mmol/l)
Measured: baseline and post 8 weeks
Lipid profile: Apo B
Evaluation of apolipoprotein B (mmol/l)
Measured: baseline and post 8 weeks
Lipid profile: Apo A
Evaluation of apolipoprotein A (mmol/l)
Measured: baseline and post 8 weeks
Insulin resistance
Evaluation of the homeostasis model assessment for insulin resistance (HOMA-IR) index
Measured: baseline and post 8 weeks
beta cell function
Evaluation of the homeostasis model assessment for β cell secretion (HOMA-β)
Measured: baseline and post 8 weeks
Body mass index (BMI)
Body weight and height weight will be combined to report BMI in kg/m^2
Measured: baseline and post 8 weeks
Anthropometric parameters
Waist and hip circumference will be combined to report waist-hip ratio
Measured: baseline and post 8 weeks
Body composition: lean mass
Lean mass distribution (%) evaluated by a whole-body dual-energy x-ray absorptiometry (DEXA) scan
Measured: baseline and post 8 weeks
Body composition: fat mass
Fat mass distribution (%) evaluated by a whole-body dual-energy x-ray absorptiometry (DEXA) scan
Measured: 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)
Measured: 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
Measured: 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 -
Measured: 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.
Measured: baseline and post 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start29 Jul 2020
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Isidori, University of Roma La Sapienza
- Investigators
- Andrea M Isidori, PHD, Principal investigator, Department of Experimental Medicine, "Sapienza" University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069324
- Sponsor's protocol ID
- PROMISE
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2020
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PrOMISE Study: PegvisOMant and the Immune SystEm
- ClinicalTrials.gov ID
- NCT05069324
- Acronym / sponsor ID
- PROMISE
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Pegvisomant, Immunity, Immune function, Metabolism, Body composition, Quality of life, Sleep disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Evaluation of inflammatory cytokines and adipokines production.
- Evaluation of glucose, insulin, c-peptide, HbA1c, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol apolipoprotein B and A. Insulin resistance and β cell function will be assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) index and for β cell secretion (HOMA-β). Anthropometric measurements will include body weight, height and waist and hip circumference.
- Evaluation of body composition. Composite outcome measure consisting of lean mass, skeletal muscle and fat distribution analysis.
- Fasting samples from all patients will be assayed for disease control parameters.
- Evaluation of quality of life. Quality of life will be measured by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical component summary score and SF-36-Item Health Survey mental component summary score and Acromegaly quality of life (AcroQol) questionnaire.
- Evaluation of sleep disturbances. Sleep disturbances will be measured by Epworth Sleepiness Scale (ESS) and by polysomnography when appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral blood mononuclear cell subpopulations
Time frame: baseline
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Change of peripheral blood mononuclear cell subpopulations
Time frame: baseline and after 8 weeks
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
31 secondary outcomes
Tumor necrosis factor alfa (TNFα)
Time frame: baseline and post 8 weeks
Transforming growth factor beta (TGF-β)
Time frame: baseline and post 8 weeks
Interleukin-1 (IL-1)
Time frame: baseline and post 8 weeks
Interleukin-6 (IL-6)
Time frame: baseline and post 8 weeks
Interleukin-10 (IL-10)
Time frame: baseline and post 8 weeks
Interferon gamma
Time frame: baseline and post 8 weeks
Monocyte chemoattractant protein (MCP-1)
Time frame: baseline and post 8 weeks
Adipokines production (visfatin)
Time frame: baseline and post 8 weeks
Adipokines production (adiponectin)
Time frame: baseline and post 8 weeks
Adipokines production (vaspin)
Time frame: baseline and post 8 weeks
Adipokines production (omentin)
Time frame: baseline and post 8 weeks
Metabolic parameters: glycemia
Time frame: baseline and post 8 weeks
Insulin production
Time frame: baseline and post 8 weeks
Insulin secretion
Time frame: baseline and post 8 weeks
Metabolic parameters: glycosylated haemoglobin
Time frame: baseline and post 8 weeks
Lipid profile: triglycerides
Time frame: baseline and post 8 weeks
Lipid profile: cholesterol
Time frame: baseline and post 8 weeks
Lipid profile: HDL-cholesterol
Time frame: baseline and post 8 weeks
Lipid profile: LDL-cholesterol
Time frame: baseline and post 8 weeks
Lipid profile: Apo B
Time frame: baseline and post 8 weeks
Lipid profile: Apo A
Time frame: baseline and post 8 weeks
Insulin resistance
Time frame: baseline and post 8 weeks
beta cell function
Time frame: baseline and post 8 weeks
Body mass index (BMI)
Time frame: baseline and post 8 weeks
Anthropometric parameters
Time frame: baseline and post 8 weeks
Body composition: lean mass
Time frame: baseline and post 8 weeks
Body composition: fat mass
Time frame: baseline and post 8 weeks
Biochemical control
Time frame: baseline and post 8 weeks
Quality of life SF-36-Item Health Survey questionnaire
Time frame: baseline and post 8 weeks
Acromegaly Quality of Life Questionnaire
Time frame: baseline and post 8 weeks
Sleep apnea
Time frame: baseline and post 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea M Isidori, PHD principal investigator
Department of Experimental Medicine, "Sapienza" University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood mononuclear cell subpopulations (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.