New research suggests that intermittent fasting may raise insulin levels, damage pancreatic cells, and increase the amount of abdominal fat.
Intermittent fasting may be a popular diet, but it may also harm our metabolic health, suggests a new study.
The so-called intermittent fasting diet has been gaining more and more traction among people who want to lose weight quickly.
This popular diet consists of “fast” days, where one drastically restricts their calorie intake — to a quarter of the daily dose or less, for instance — and “feast” days, where the person dieting can eat whatever they please.
Sometimes referred to as a dieting “fad,” intermittent fasting has become popular in recent years, due to its suggested benefits of increasing lifespan and staving off cancer.
Indeed, some animal studies have indicated that intermittent fasting may lower the risk of cancer, while observational studies have shown that people whose religion has them fasting regularly live longer than seniors who do not fast.
But could there also be downsides to intermittent fasting? Research presented at the European Society of Endocrinology annual meeting — which took place in Barcelona, Spain — suggests that the dieting practice may have serious consequences for a person’s metabolism.
Specifically, the new study — led by Ana Cláudia Munhoz Bonassa, a researcher at the University of São Paulo in Brazil — suggests that intermittent fasting may impair the normal activity of the pancreas and the production of insulin, which may, in turn, raise the risk of type 2 diabetes.
Intermittent fasting may lead to diabetes
The researchers were prompted in their endeavor by older studies suggesting that fasting for a short period of time increases oxidative stress and the production of free radicals.
Oxidative stress and excessive levels of free radicals have been suggested to speed up the aging process and to damage our DNA, raising the risk of cancer, cardiovascular disease, and neurodegeneration.
To find out whether intermittent fasting does indeed generate free radicals, Bonassa and her colleagues placed healthy, adult rats on the diet for a period of 3 months.
During this time, the researchers measured and monitored the rodents’ insulin levels and function, their body weight, and their free radical levels.
At the end of the dieting period, the rats had lost weight, as expected. However, the distribution of their body fat changed unexpectedly.
The amount of fat tissue in the rodents’ abdomen increased. Belly fat has been shown by recent studies to be deeply linked with type 2 diabetes, with some research even suggesting a molecular mechanism through which the former may lead to the latter.
Additionally, Bonassa and colleagues found damage in the insulin-secreting pancreatic cells, as well as higher levels of free radicals and signs of insulin resistance.
The study’s lead author comments on the findings, saying: “We should consider that overweight or obese people who opt for intermittent fasting diets may already have insulin resistance.”
“[S]o,” Bonassa continues, “although this diet may lead to early, rapid weight loss, in the long-term there could be potentially serious damaging effects to their health, such as the development of type 2 diabetes.”
“This is the first study to show that, despite weight loss, intermittent fasting diets may actually damage the pancreas and affect insulin function in normal healthy individuals, which could lead to diabetes and serious health issues.”
Ana Cláudia Munhoz Bonassa
In future, the scientists plan to study in more detail the damaging effects of intermittent fasting on the normal functioning of the pancreas and the insulin hormone.
A new outbreak of the Ebola virus that has killed at least two dozen people has set public health officials scrambling to contain the epidemic as it threatens to spread far beyond the remote jungles of the Congo River Basin — and raises new questions about the World Health Organization’s (WHO) preparations for the next killer virus.
The U.S. government is preparing its most direct response yet to the outbreak that appears to have begun in April, readying staffers from the Centers for Disease Control and Prevention (CDC) to deploy to multiple communities in the Democratic Republic of Congo.
Ministry of Health officials first identified cases of viral hemorrhagic fever when it reached the town of Bikoro earlier this month. On Thursday, officials said a new case had been identified in Mbandaka, a city of 1.2 million.
The new case in Mbandaka has raised the alarm among public health officials because it is the first time the virus has ever landed in a city that sits directly on the Congo River.
In all eight of the previous known Ebola outbreaks in the Democratic Republic of the Congo, the virus has been contained within remote jungle villages or relatively small towns, where isolated populations are less likely to spread the disease.
But the Congo River is effectively the region’s highway system. Barges and boats travel from Kisangani in the east through major cities including Bumba, Mbandaka — and eventually Kinshasa, the capital of the DRC and home to more than 11 million people, as well as Brazzaville, the capital of the Republic of Congo.
“The Congo River connects three national capitals and multiple other large cities,” said Jeremy Konyndyk, who served as head of USAID’s Office of Foreign Disaster Assistance during the 2014-2015 outbreak. “The fact that there are now several cases in an urban center of more than a million people underscores the potential for this outbreak to get out of control.”
If the Ebola virus traveled upriver from Bikoro to Mbandaka, some officials wonder, has it also traveled downstream toward Kinshasa, which offers direct air traffic to cities including Brussels, Paris, Dubai and Lagos, Nigeria?
“We don’t know what’s happening along the river, because the river is used by a lot of barges,” said Pierre Rollin, one of the world’s leading experts on the Ebola virus at the CDC. “None of the outbreaks have been by the river or in the big towns. So we have a lot of caution before claiming we know what’s going on.”
Previous outbreaks have been snuffed out in the Congo, Rollin said, because the area is so remote that humans did not have a chance to travel far enough to transmit the virus before succumbing.
That was not the case four years ago in West Africa, where the virus spread widely across international boundaries. Commercial and cultural travel throughout Guinea, Liberia and Sierra Leone — across borders drawn a century and a half ago by colonizers with little regard for traditional tribal boundaries — is far more common than it is in the Congo.
The present outbreak has raised anew questions about WHO and its capacity to respond to deadly viral threats. In the wake of the West African outbreak ago, when the ill-prepared WHO endured withering criticism for its lackluster response to the initial round of cases, the agency has undergone a remarkable round of self-flagellation, reorganizing to prioritize emergency preparedness and response while cutting bureaucracy.
“We’ve seen WHO activate much more quickly, at much larger scale, and in more effective partnership with players like” Doctors Without Borders, said Konyndyk, who sat on an independent panel that advised WHO on reforming its emergency functions after the West Africa outbreak.
The first WHO investigative team arrived in Bikoro on May 5, about a month after the first suspected cases are likely to have emerged in Ikoko Impenge. A logistics team arrived on May 9, and the United Nations began daily flights carrying supplies and personnel between Kinshasa and Mbandaka on May 13.
Tedros Adhanom Ghebreyesus, the WHO’s director general, visited Bikoro on May 13, in part to show the urgency of the situation.
“A major lesson learnt from the West Africa Ebola outbreak was that WHO needed a flexible fund to rapidly respond to outbreaks and emergencies,” Tarik Jasarevic, a WHO spokesman, said in an email from Geneva. The agency’s new Contingency Fund for Emergencies, already activated in the Congo, has made cash available to responders far more quickly than in the case of West Africa.
Still, some wonder why it took the Congolese Ministry of Health and the WHO a month to spot the virus in the first place.
“We are doing better at response, but not much better at rapid detection, which is important,” said Tom Frieden, the former CDC director who now runs the public health organization Resolve to Save Lives. “This was spreading for a while before [it was] recognized.”
Aiding the response further is a new vaccine, finalized in the last days of the West Africa outbreak. About 4,000 doses of the vaccine are headed to the epicenter of the new outbreak, where they will be used in two ways: First, health care workers, those most vulnerable to exposure, will be vaccinated. Then, those who have come into contact with anyone infected, and the contact’s contacts, will be vaccinated, a practice known as ring vaccination.
“That part should really add another arm to the response. It’s not the response by itself, because you still have to do all the rest,” Rollin said.
The Democratic Republic of the Congo is also far more prepared to respond to an Ebola outbreak because the virus is known to be endemic to the region. The first modern outbreak of the Ebola virus occurred in the village of Yambuku, about 370 miles from the site of the present one, back in 1976.
The biotech analysts at Cantor Fitzgerald have a packed calendar: here are some of the dates they’re tracking and why they’re important.
Mallinckrodt PLCMNK 2.3% is expected to release Phase 4 interim Acthar data for multiple sclerosis at the end of May, rheumatoid arthritis in June and systemic lupus erythematosus at some point in the second quarter.
Mylan NVMYL 1.05%’s Neulasta and Advair biosimilars have June 4 and June 27 Target Action Dates, respectively. Cantor forecast June oral arguments for challenged Restasis patents and a second-quarter launch of Cimduo.
Teva Pharmaceutical Industries Ltd (ADR) ADRTEVA 0.52%’s injectable CGRP fremanezumab has a June 16 PDUFA date, and Cantor anticipates approval and launch before the end of the year.
Valeant Pharmaceuticals Intl IncVRX 0.5% is expected to secure approval for Duobrii June 18 and release Phase 3 data for IPD-123 in the second quarter.
Arsanis IncASNS 1.88% will report Phase 2 interim results for ASN100 in late June.
Dermira Inc DERM 0.83%’s DRM04 has a June 30 PDUFA date, and management will host an investor day May 24.
Nabriva Therapeutics PLC – ADR NBRV 4.83% is expected to report Phase 3 Lefamulin data in late spring.
Amneal Pharmaceuticals IncAMRX 2.14% plans to launch generic Welchol and begin its Rytary trial with Teva sometime in the second quarter.
Aclaris Therapeutics IncACRS 1.99% is expected to release Phase 2 data for ATI-502 in the second quarter.
Shire PLC (ADR) SHPG 1.19% anticipates approval for its Covington manufacturing facility in June or July.
Heron Therapeutics IncHRTX 2.1% expects top-line results for its HTX-011 studies toward the end of the second quarter.
Cidara Therapeutics IncCDTX 1.05% plans to announce a development candidate midyear.
Spero Therapeutics IncSPRO 0.33% will report Phase 1 data for SPR994 by mid-2018 with the second quarter bringing results for a Phase 1b study of SPR741 and preclinical study of SPR206. SPR994 will begin a Phase 3 trial at the end of the year.
Theravance Biopharma IncTBPH 0.69% will report Phase 2a data for TD-9855 by the end of July, has a Nov. 13 PDUFA date for TD-4208 and will begin reporting Phase 1b data for its JAK inhibitor in the back half of 2018.
Allergan plcAGN 1.12% has a PDUFA date for Esmya in August; anticipates Sarecycline approval and the release of Abicipar Phase 3 data in the second half of 2018; and will report Rapastinel Phase 3 data in 2019. Cantor Fitzgerald expects Phase 2b data for oral CGRP atogepant and Phase 2 data for pilocarpine/oxymetazoline in the second half of 2018.
Endo International PLCENDP 1.61% will report Phase 3 data for Xiaflex by the first quarter of 2019.
Paratek Pharmaceuticals IncPRTK 1.32% will report Phase 2 data for Omadacycline cUTI in the second half of 2019.
Opko Health Inc.OPK 18.24% is expected to release interim Phase 2b data for OPK88004.
BottomLine: U.S military personnel with low back pain who received usual medical care plus chiropractic care reported moderate improvement in their pain intensity and disability compared with patients who received usual medical care alone.
Why The Research Is Interesting: Low back pain is one of the most common reasons service members in the U.S. military seek medical care. Common therapies for low back pain include nonsteroidal anti-inflammatory drugs, opioids, spinal fusions and edpidural steroid injections. An opioid crisis in the United States has created an urgent need to evaluate cost-effective and low-risk nonpharmacological treatments for low back pain. One of those options is chiropractic care.
Who and When: 750 active-duty U.S. service members enrolled in a clinical trial at three military sites (250 at each site) conducted from September 2012 to February 2016
What (Study Interventions and Measures): Usual medical care (self-care, medications, physical therapy and pain clinic referral) or usual medical care plus chiropractic care (spinal manipulation in the low back and adjacent areas plus additional procedures such as rehabilitative exercise, cryotherapy, superficial heat and other manual therapies) over six weeks (interventions); low back pain intensity and disability scores (main outcomes)
How (Study Design): This was a clinical trial. Clinical trials allow for the strongest inferences to be made about the true effect of an intervention such as a medication or a procedure. However, not all clinical trial results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied.
Authors: Christine M. Goertz, D.C., Ph.D., formerly of Palmer College of Chiropractic and now with Spine IQ (The Spine Institute for Quality), Davenport, Iowa, and coauthors
Study Limitations: Differences in participant characteristics, treatments received and outcomes across sites, as well as a short follow-up
Study Conclusions: Changes in pain intensity and disability reported by U.S. military personnel in this clinical trial that supports usual medical care plus chiropractic care for low back pain are consistent with existing literature on spinal manipulation therapy in both military and civilian populations.
A multi-center study that validates the clinical performance of IsoPSA – a new blood test that has proven to be more accurate in predicting overall risk of prostate cancer than standard prostate-specific antigen (PSA) – will be presented during a special press conference at the 13th Annual Meeting of the American Urological Association (AUA) on May 18 in San Francisco.
Results showed that more than 40 percent of biopsies could have been avoided in both the preliminary study (45.1 percent) and validation study (47 percent), suggesting that use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.
The study, Prospective Validation of the IsoPSA Assay for Detection of High Grade Prostate Cancer, was conducted as a follow-up to early studies which demonstrated that IsoPSA, a structure-focused protein biomarker, may be an effective means of discriminating between high-grade prostate cancer (Gleason≥7) and low-grade/benign disease (Gleason=6).
The research team, led by Cleveland Clinic’s Eric Klein, M.D., conducted a multicenter validation trial and evaluated performance data with a new cohort, including cutoff parameters derived from a preliminary study, using the detection of cancer by biopsy as the endpoint.
“To be clinically useful, a biomarker must be both tissue-specific and cancer-specific. While PSA is prostate-specific, it is not specific for prostate cancer, leading to diagnostic inaccuracy and too many unneeded biopsies,” said Dr. Klein, chair of Cleveland Clinic’s Glickman Urological & Kidney Institute. “IsoPSA fulfills both the tissue- and cancer-specificity needed for a useful biomarker, and this validation study shows that it can more accurately detect high-grade cancer and reduce the rate of unneeded biopsies in patients at low risk of this disease.”
The IsoPSA test was developed by Cleveland Diagnostics, a company co-founded by Cleveland Clinic, in which it has financial interest. Dr. Klein has no personal financial interest in the company. Mark Stovsky. M.D., a Cleveland Clinic urologist and co-author on the study, has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics. In late 2017, Cleveland Diagnostics and Genomic Health announced an exclusive licensing agreement to develop and commercialize the IsoPSA test.
The U.S. Food and Drug Administration said on Wednesday the harvest season for romaine lettuce, linked to the multi-state E. coli outbreak, was over and it was unlikely that it was still available in stores due to its 21-day shelf life.
The reported strain of E. coli, which produces poisonous substances known as Shiga toxins, can cause severe abdominal cramps, bloody diarrhea and vomiting.
The Centers for Disease Control and Prevention said on May 2 one person from California had died related to the E. coli outbreak.
The last shipments of romaine lettuce from Yuma, Arizona were harvested on April 16, according to the FDA. (bit.ly/2GT7v6b)
Twenty-three more people fell ill since the last update on May 9, bringing the total to 172 people from 32 states, the CDC said on Wednesday. (bit.ly/2HhtHu6)
Three more states — Iowa, Nebraska, and Oregon — have also reported cases, the CDC said.
The nonprofit health system’s CEO talks about the acquisition of the nation’s second-largest post-acute care company and expectations of surging demand for long-term care and home health services.
ProMedica Health System President and CEO Randy Oostra spoke with HealthLeaders Media about the Toledo-based health system’s$3.3 billion acquisition of HCR ManorCare in a joint partnership with Welltower, the real estate investment trust.
The following is a lightly edited transcript.
HLM: What makes this a good time to acquire HCR ManorCare?
Oostra: Like most systems, we are looking at the future and all the disruption going on, and you realize a lot of the lines are blurred between what we have traditionally done.
Randy Oostra
We are in a non-growth market. How do we grow as a system? How do we begin to diversify? We have a health plan, we have hospitals, we have a physician group. Being more diversified in this space made sense.
Then you look at the trends, whether it’s the number of 85-year-olds, or the numbers of people who are going to get Alzheimer’s, home health numbers, hospice numbers, etc. You see all this massive growth, but the people moving in that space are venture capital companies.
The more we talked to ManorCare as they were going through their issues, it made a lot of sense. It went from an interesting idea to “why didn’t we do this before?” Plus, they are a locally based company. It gives us scale and opportunities that we hadn’t had before.
HLM: Is ProMedica venturing into post-acute care because of the demographics pressures, or because you anticipate a change in the way care is delivered to seniors?
Oostra: It’s both. Not many Baby Boomers want to go to a hospital. They want to stay home. Who is going to develop those services? Why wouldn’t that be hospitals? The expectations are going to change, so as we delivery these services we are going to have to change as well. It’s exciting to think about, this blurring of the lines.
HLM: Did you buy ManorCare because it was bankrupt, or were you looking to move into post-acute services beforehand?
Oostra: We started discussions two or three years ago, before their more recent issues. We did a partnership on one of our campuses here in Sylvania, Ohio. They have a Heartland facility on our Flower hospital campus. We began discussions even back then that maybe we ought to work together and maybe you ought to be a nonprofit. Their initial reaction was “are you people crazy?”
ManorCare is one of the best operators in this space in the country. We think there are opportunities to get more efficient. We think there are ways to get together through telehealth and urgent care through our physician group, maybe exploring some options with our health plan.
Overnight we went from a $3 billion system to a $7 billion system, from 17,000 to 70,000 employees, from facilities in five states to 30 states. We put a lot of emphasis on the skilled nursing piece, but there are other pieces. The home health piece, assisted living, rehab and hospice pieces are incredibly profitable. We have some ideas about how to grow that.
When we look at what we were able to structure on the SNFs with Welltower, the reduction in lease rates, the balance of what we are able to provide with our current system and the growth in other areas, we became comfortable that in a short period of time we can drive that 3% to 4% operating margin on a larger scale, and that is how we got comfortable that this was a great strategic step for us.
HLM: ManorCare was in Chapter 11. What will you do differently to make it profitable?
Oostra: Right now, with everything from sales taxes to real estate taxes, we’ve done a fair amount of research on how to convert to nonprofit status. We are fairly proximate to one another. In a $7 billion company there are some great opportunities for synergies. Also, the lease rates we will be paying are significantly lower than they were paying in the past. It only takes a couple of those factors to turn them profitable.
In some ways this is not that different as when hospitals merge. You have to look at the same areas, the same management services.
HLM: ManorCare has a significantly larger footprint. How will you coordinate care in outlying facilities that might be several states away from your Ohio base?
Oostra: In some of the states where they have a smaller footprint, maybe we will exit certain markets. In each case we will look at what we can bring that’s consistent with our system and in other cases we will partner locally. It’s going to be on a one-by-one, market-by-market basis. As we work over the next year those are the things we’ll look at.
HLM: What is the status of ManorCare under ProMedica?
Oostra: They are fully part of ProMedica. They will be one of our divisions. They will be our employees. We will own 100% of HCR ManorCare. On the real estate side, we will own 20% of the real estate in a joint venture with Welltower. HCR will be fully integrated in our system.
HLM: Are you in uncharted waters with this acquisition?
Oostra: I hate to say we are in uncharted waters here, but it seems to be a unique, first-of-its-kind partnership. A nonprofit health system, a large post-acute provider and a real estate investment trust as partners is unique.
This is different from other deals we’ve done where you talk through mission, vision, values and culture and then you come to the business model. This was all about the business model, and it had to work because of where they were with this bankruptcy. It’s the opposite of what we’ve done in the past, where you build up to the financial model and that’s toward the end. This was first, and this was all about the economic model. Does it work? Can we exit bankruptcy?
But, we know ManorCare and Welltower. We are confident that we will figure out some of the other stuff as we move along.
HLM: With this acquisition, you will more than double in size. Are there any particular areas in this deal that you view as potentially problematic, and what are you doing about it?
Oostra: The fear is the fear of the unknown. We are all at the mercy of reimbursements. I don’t think the post-acute world can face further reimbursement cuts, especially when you see what’s happened in the past. That’s the sort of thing we worry about the most.
We are comfortable that we can operate and grow, unless something further happens to devastate the financials of skilled nursing facilities.
On the other side, the home health, hospice, assisted living, rehab, memory care, those are all more profitable and if we can grow those while managing the skilled nursing at a break even or better margin we are going to be fine.
HLM: What metrics will you use to determine if you’re succeeding?
Oostra: Right now we are taking a hard look at quality and safety. We would look at many of the metrics for performance in the nursing home world. We’re looking to grow, so financial metrics are important. We talk about balancing out between skilled vs. nonskilled. We will be cognizant in growing in some of the nonskilled areas to balance out the financial portfolio. Those are the first pass metrics.
HLM: Are you nervous about being in the vanguard?
Oostra: We talk a lot in healthcare about how we need to change, how we need to disrupt. But some of the people who would say that would be the first people who will criticize us for doing this. We are in a non-growing market. We have to think nontraditionally.
For most of our careers, once you left the hospital, good luck! We didn’t pay attention until it hit our finances and all of a sudden we were worried about readmissions. We look at this as the next step. If we are going to care for all these people beyond our traditional hospital walls, why wouldn’t we move into that space? Why wouldn’t we do it quicker and why don’t we move in even more. It makes sense to us.
