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Clinical Trials Office Newsletter
November 2025 Edition
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Research Spotlight: Metformin and Exercise
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This month, we are highlighting a recently published study which was conducted with the support of the RWJMS Clinical Research Center. To test the theory that Metformin, a commonly prescribed diabetes drug, sabotages the benefit of exercise, Dr. Steven Malin, a professor in the Department of Kinesiology and Health in the School of Arts and Sciences, conducted a study to do exactly that. Dr. Malin’s team recruited 72 adults at risk for metabolic syndrome, a cluster of conditions that raise the risk of diabetes and heart disease. They divided the trial participants into four groups: people performing high-intensity exercise while taking a placebo, high-intensity exercise with metformin, low-intensity exercise with a placebo, and low-intensity exercise with metformin.
Over 16 weeks, researchers tracked changes in blood vessel function under insulin stimulation, a process that helps vessels dilate and deliver oxygen, hormones and nutrients after meals.
The results were clear: exercise alone improved vascular insulin sensitivity, meaning blood vessels responded better to insulin and allowed more blood flow to muscles. This matters because insulin’s ability to open blood vessels helps shuttle glucose out of the bloodstream and into tissue, lowering blood sugar after meals.
But when metformin was added, the improvements shrank. The drug also diminished gains in aerobic fitness and reduced the positive effects on inflammation and fasting glucose.
This matters because exercise is supposed to lower blood sugar and improve physical function, crucial goals of diabetes treatment. If metformin interferes with those benefits, patients may not get the protection they expect to help lower disease risk.
Why does metformin blunt exercise benefits? The answer is unclear but, according to Dr. Malin, may lie in the drug’s mechanism of action. Metformin works partly by blocking parts of the mitochondria, which reduces oxidative stress and improves blood sugar control. But that same inhibition may interfere with the cellular adaptations triggered by exercise, including improvements in mitochondrial function and aerobic capacity. In other words, the very process that makes metformin effective may block the body’s ability to respond fully to physical training.
Previous research has hinted at similar effects, but this trial is among the first to examine vascular insulin sensitivity, which is a key factor controlling glucose regulation and cardiovascular health. By showing that metformin can blunt improvements in both large arteries and tiny capillaries regardless of exercise intensity, the study underscores the complexity of combining such treatments.
Dr. Malin and his team are also recruiting for a new exercise study: NCT06546085 (Extracellular Vesicles, Insulin Action, and Exercise)
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Top left to right: Jackie Dosik, Nate Stewart, Brielle Dotson, Emily Heiston, Udeyvir Cheema
Bottom left to right: Daniel Battillo, Mary Remchak, Tristan Ragland, Steven Malin, Afsheen Syeda, Habiba Faiz, Anna Ballantyne
| | Congratulations Dr. Malin, the Malin Lab team, and the RWJMS Clinical Research Center! | | Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow Rutgers Health study teams! | | Decentralized Trial Design | | |
Monday, December 1st, 2025
12:00 pm
| | Christopher Lindsell, PhD | | Duke Clinical Research Institute | | Decentralized trials are studies where some or all of the activities occur at locations convenient to the participants such as their home. Spurred on by innovation in remote, virtual and touchless procedures necessitated by the Covid-19 pandemic, decentralized trials are increasingly mainstream. As research activities move away from the direct control of the site investigator in a clinical setting, the nature of participant involvement changes with effects that are both subtle and profound. This talk will compare and contrast decentralized and traditional study approaches to highlight the strengths, weaknesses, and opportunities of decentralized trials. | | |
Regulatory Tip of the Month
| | Important changes to US tax law for 2026 impacting research participant payments | | |
H.R.1, also known as One Big Beautiful Bill Act which was passed by Congress and signed into law this past July, contained a provision which raises the reporting threshold for IRS Form 1099-MISC from $600 to $2000, starting on 1/1/26. Since clinical research participant payment income is reported on the 1099-MISC, this change will have operational impacts. While participant payments for research continue to be viewed as taxable income, this increase in the reporting threshold means that participants will only be required to report their research payments on the 1099-MISC if they have earned $2000 or more in a calendar year beginning in 2026 (instead of the current threshold of $600 per year.)
While this is truly welcome news for our research participants as well as for study teams and administrators, we would like to emphasize the following points:
- Changes to the Rutgers Human Subjects Payment Policy are still pending at this time. Specifically, we are awaiting a decision as to how the Rutgers Tax Office will implement the change to the law. This includes whether they will opt to issue the 1099-MISC only once the $2000 threshold has been met as well as the thresholds for the anticipated annual payment per participant on a study and the single payment value which will trigger a requirement for the study team to collect the participant’s social security number or TIN (the thresholds are currently set at $300 and $100 respectively.)
- Once Rutgers policy has been established, study informed consent forms will need to be amended and participants will need to be reconsented if warranted.
- ClinCard/Greenphire Patient Payments will be re-configured to align with the new law and with Rutgers policy.
Stay tuned, and please feel free to reach out with any questions to ClinCard@rbhs.rutgers.edu
| | Congratulations and a fond farewell to Arleen Wallen | |
Please join us as we wish Arleen Wallen, Administrative Director for UH-Newark’s Clinical Research Services, best wishes for her upcoming retirement. Arleen’s final day at UH-Newark will be on 11/21.
Arleen came to UH-Newark in 2015, with a wealth of experience as a clinical research administrator at Temple University in Philadelphia. Her arrival came at a time when hospital and Rutgers leadership were still learning how to operate as independent partners in clinical research, following the separation of the hospital from NJMS in 2013. Arleen used her experience and insights to develop new workflows and to build a competent and effective research infrastructure at UH.
Arleen’s leadership, professionalism, extensive knowledge of clinical research operations, but, most of all, her warmth and friendship to Rutgers study teams and investigators will be truly missed. Arleen: We wish you health, happiness and much deserved rest as you start this next chapter!
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Have you encountered problems after clicking the "Review Document" link in a Docusign email, especially if it is Part 11-compliant? Instead of using the email link, open a new browser tab, go directly to the Docusign website, and log in. The document should be accessible in your dashboard under the "Action Required" section.
If you still are encountering trouble, reach out to Sam Lee (samuel.s.lee@rutgers.edu).
Thank you, Scot Stenroos, for this tip.
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Happy Halloween from
PCRC Recover 3 Team
| | Left to Right: Christian Suarez CRC, Bibiana Vargas Forero CRC, Christina Varghese CRC, Damaris Soto admin assistant | | Dr. Sugeet Jagpal Named to a Leadership Position in the Adult CRC | |
Sugeet Jagpal, MD, associate professor in the medical school's Division of Pulmonary and Critical Care Medicine, has been named associate director of the Adult Clinical Research Center (CRC).
A faculty member since 2014, Dr. Jagpal has been active in the Cystic Fibrosis (CF) Center, including the CF research network, and has been principal investigator and sub-investigator on numerous clinical trials, several of which reached top enrollment goals for the country. From 2016 to 2017, she participated in a research mentoring program designed to increase the culture of research in CF research centers. She completed the American College of Research Investigators Certification in September 2017. In addition to CF trials, Dr. Jagpal served as sub-investigator in COVID-19 trials, critical care trials, non-CF bronchiectasis and asthma/COPD trials.
Through all these experiences, Dr. Jagpal developed deep knowledge of all aspects of clinical trial implementation, including facilitators and barriers to successful recruitment and operations, and the regulatory and ethical framework of clinical trials. Her well-honed leadership skills have been evident in her work with the CF Foundation, the Critical Care Fellowship, and the American Thoracic Society. Her interpersonal skills and experience working with faculty and staff throughout the medical school and within the CRC environment, combined with her forward-looking attitude when dealing with challenging issues related to clinical trials, will be an asset for her new role.
As associate director of the Adult CRC, Dr. Jagpal will work with Sunanda Gaur, MD, professor and director of the medical school's Clinical Research Center, to develop growth strategies and assist with high-level oversight of clinical trials being conducted and under consideration at the Adult CRC. She also will provide oversight coverage when Dr. Gaur is absent.
Welcome, Dr. Jagpal, to this new role!
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Reminder: Regulatory consults are available through the NJ ACTS Regulatory Support Team | |
The NJ ACTS Regulatory Core offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. The goal is to provide the NJ ACTS community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research.
Please visit our webpage: https://njacts.rbhs.rutgers.edu/investigator-resources/regulatory/ or request a consult through this link:
Regulatory Consultation Form
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Clinical Research Pet of the Month
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November's clinical research pet of the month is Holly. Her pet parent is Dr. Manisha Bajpai, clinical trials research manager for the RWJMS Cardiology Division.
Holly is a 7-year-old brindle Shepherd Retriever mix, has a heart of gold and a body built for maximum cuddles. She’s sweet, intelligent, affectionate, and oh-so-polite. Whether it’s a game of fetch, a cozy cuddle on the couch, or strutting her stuff to show off her skills, Holly is always ready to share her joy.
She’s a bit selective about other dogs, none allowed near her home, but she takes her role as guardian seriously, chasing away any rabbits or deer that dare enter her territory. Holly adores humans of all ages, from tiny tots to grown-up cuddlers, and is always up for an adventure (or a snuggle session). When it comes to food, she’s not much of an eater, she’ll happily pick out the treats and leave the rest behind!
| | Congratulations to Holly and Manisha! | | | | |
