PegvisOMant & the Immune SystEm (PROMISE)

Status Completed

Clinical 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 resistance, metabolic complications and fat accumulation.

Clinical Trial 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

Related Conditions & MeSH terms

Acromegaly

Clinical Trial Details

NCT number	NCT05069324
Study type	Observational
Source	University of Roma La Sapienza
Contact
Status	Completed
Phase
Start date	July 29, 2020
Completion date	June 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06344650` - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting	`NCT02092129` - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.	N/A
Completed	`NCT02012127` - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting	`NCT01265121` - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.	N/A
Terminated	`NCT00765323` - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly	Phase 3
Completed	`NCT00531908` - Physiopathology of Sodium Retention in Acromegaly	N/A
Completed	`NCT00500227` - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed	`NCT01278342` - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients	Phase 4
Active, not recruiting	`NCT01809808` - A Prospective Study of Outcome After Therapy for Acromegaly
Completed	`NCT00145405` - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction	Phase 4
Completed	`NCT00210457` - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients	Phase 3
Recruiting	`NCT05401084` - Diet in the Management of Acromegaly	N/A
Recruiting	`NCT00005100` - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly	N/A
Completed	`NCT00521300` - Preoperative Octreotide Treatment of Acromegaly	Phase 4
Completed	`NCT03548415` - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands	Phase 2
Not yet recruiting	`NCT04066569` - Reproducibility and Utility of OGTT in Acromegaly	N/A
Not yet recruiting	`NCT05298891` - Hypoproteic Diet in Acromegaly	N/A
Recruiting	`NCT04520646` - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy	N/A
Not yet recruiting	`NCT04529356` - The TMS Treatment for Postoperative Headache in GH Tumor	N/A
Active, not recruiting	`NCT03252353` - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PegvisOMant and the Immune SystEm (PROMISE)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms