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result(s) for
"Pierce, Doris R."
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Effect of experimental hookworm infection on insulin resistance in people at risk of type 2 diabetes
by
Field, Matthew A.
,
Hii, Sze Fui
,
Merone, Lea
in
631/250/256/2515
,
692/163/2743/137/773
,
692/699/255/1715
2023
The reduced prevalence of insulin resistance and type 2 diabetes in countries with endemic parasitic worm infections suggests a protective role for worms against metabolic disorders, however clinical evidence has been non-existent. This 2-year randomised, double-blinded clinical trial in Australia of hookworm infection in 40 male and female adults at risk of type 2 diabetes assessed the safety and potential metabolic benefits of treatment with either 20 (
n
= 14) or 40 (
n
= 13)
Necator americanus
larvae (L3) or Placebo (
n
= 13) (Registration ACTRN12617000818336). Primary outcome was safety defined by adverse events and completion rate. Homoeostatic model assessment of insulin resistance, fasting blood glucose and body mass were key secondary outcomes. Adverse events were more frequent in hookworm-treated participants, where 44% experienced expected gastrointestinal symptoms, but completion rates were comparable to Placebo. Fasting glucose and insulin resistance were lowered in both hookworm-treated groups at 1 year, and body mass was reduced after L3-20 treatment at 2 years. This study suggests hookworm infection is safe in people at risk of type 2 diabetes and associated with improved insulin resistance, warranting further exploration of the benefits of hookworms on metabolic health.
A beneficial effect of parasitic worms on metabolic health has been postulated based on epidemiological and animal studies. Here, the authors show in a phase I clinical trial that treatment of people at risk of type 2 diabetes with hookworms is safe and may improve key measures of metabolic health.
Journal Article
Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A
2022
Patients with severe hemophilia A were treated with an adenoviral construct containing coagulation factor VIII cDNA and followed for 1 to 3 years. Median factor VIII activity at 49 to 52 weeks was 24 IU per deciliter, and annualized bleeding rates decreased after treatment. Elevations in alanine aminotransferase were the most common toxic effect and were mainly controlled with glucocorticoids.
Journal Article
Patient-Perceived Benefits and Limitations of Standard of Care Remote Symptom Monitoring During Cancer Treatment
2024
Introduction
Remote symptom monitoring (RSM) allows patients to electronically self-report symptoms to their healthcare team for individual management. Clinical trials have demonstrated overarching benefits; however, little is known regarding patient-perceived benefits and limitations of RSM programs used during patient care.
Methods
This prospective qualitative study from December 2021 to May 2023 included patients with cancer participating in standard-of-care RSM at the University of Alabama at Birmingham (UAB) in Birmingham, AL, and the Univeristy of South Alabama (USA) Health Mitchell Cancer Institute (MCI) in Mobile, AL. Semi-structured interviews focused on patient experiences with and perceptions surrounding RSM participation. Interviews occurred over the phone, via digital videoconference, or in person, at the convenience of the patient. Grounded theory was used to conduct content coding and identify recurring themes and exemplary quotes using NVivo.
Results
Forty patients (20 UAB, 20 MCI) were interviewed. Participants were predominately female (87.5%), aged 41-65 (50%), and married (57.5%). Data is consistent with local demographics, comprising mainly White (72.5%) and 27.5% Black individuals. Three main themes emerged regarding perceived benefits of RSM: (1) Facilitation of Proactive Management, identifying the patient’s needs and intervening earlier to alleviate symptom burden; (2) Promotion of Symptom Self-Management, providing patients autonomy in their cancer care; and (3) Improvement in Patient-Healthcare Provider Relationships, fostering genuine connections based on healthcare team’s responses. However, participants also noted Perceived Limitations of RSM; particularly when support of symptom management was unnecessary, ineffective, or felt impersonal.
Conclusion
This study focused on patient experiences when utilizing a RSM program while undergoing treatment for cancer and found benefits to its implementation that extended beyond symptom management. At the same time, patients noted drawbacks experienced during RSM, which can help with future tailoring of RSM programs. Patient perceptions should be regularly assessed and highlighted for successful and sustained implementation.
Plain language summary
Cancer and its treatment can cause patients to experience many forms of symptoms. This can have a major effect on their overall well-being: physically, mentally, and emotionally. Early symptom detection and management has been shown to significantly improve the quality of life of patients with cancer. Remote symptom monitoring (RSM) allow patients to report their symptoms to their healthcare team and receive personalized feedback and management from them, without having to leave the comfort of their home. Although previous studies have shown the overarching benefits of implementing RSM during care, little is known regarding how patients perceive its implementation. This research team wanted to gain a better understanding of perceptions patients had, whether good or bad, of RSM’s implementation while they were actively undergoing cancer care. A total of 40 patients were interviewed with patients commenting on RSM’s ability to facilitate proactive management, promote symptom self-management, and improve patient-healthcare provider relationships. Patients also had feelings that under certain circumstances, RSM did have some limitations. This study was able to help identify some of the perceived benefits and limitations to RSM implementation. This feedback will not only help to ensure the successful implementation of future RSM programs but will also let patients know that they are heard and that their feedback is pivotal.
Journal Article
Safety and tolerability of experimental hookworm infection in humans with metabolic disease: study protocol for a phase 1b randomised controlled clinical trial
2019
Background
Abdominal obesity and presence of the metabolic syndrome (MetS) significantly increase the risk of developing diseases such as Type 2 diabetes mellitus (T2DM) with escalating emergence of MetS and T2DM constituting a significant public health crisis worldwide. Lower prevalence of inflammatory and metabolic diseases such as T2DM in countries with higher incidences of helminth infections suggested a potential role for these parasites in the prevention and management of certain diseases. Recent studies confirmed the potential protective nature of helminth infection against MetS and T2DM via immunomodulation or, potentially, alteration of the intestinal microbiota. This Phase 1b safety and tolerability trial aims to assess the effect of inoculation with helminths on physical and metabolic parameters, immune responses, and the microbiome in otherwise healthy women and men.
Methods
Participants eligible for inclusion are adults aged 18–50 with central obesity and a minimum of one additional feature of MetS recruited from the local community with a recruitment target of 54. In a randomised, double-blind, placebo-controlled design, three groups will receive either 20 or 40 stage three larvae of the human hookworm
Necator americanus
or a placebo. Eligible participants will provide blood and faecal samples at their baseline and 6-monthly assessment visits for a total of 24 months with an optional extension to 36 months. During each scheduled visit, participants will also undergo a full physical examination and complete diet (PREDIMED), physical activity, and patient health (PHQ-9) questionnaires. Outcome measurements include tolerability and safety of infection with
Necator americanus
, changes in metabolic and immunological parameters, and changes in the composition of the faecal microbiome.
Discussion
Rising cost of healthcare associated with obesity-induced metabolic diseases urgently calls for new approaches in disease prevention. Findings from this trial will provide valuable information regarding the potential mechanisms by which hookworms, potentially via alterations in the microbiota, may positively influence metabolic health.
Trial registration
The protocol was registered on
ANZCTR.org.au
on 05 June 2017 with identifier
ACTRN12617000818336
.
Alternatively, a Google search using the above trial registration number will yield a direct link to the trial protocol within the ANZCTR website.
Journal Article