Researchers collaborate to examine mystery illness that plagues women

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(L-R) Rachele Berria, M.D., research fellow in the department of medicine/diabetes, and Scott Lucidi, M.D., assistant instructor of ob-gyn at The University of Texas Health Science Center at San Antonio, talk to study participant Jessica Garza about what she can expect throughout the Polycystic Ovary Syndrome (PCOS) study. Garza travels from the Valley to participate in the study.

San Antonio (March 23, 2004) – Acne, excessive hair growth, weight gain and infertility – these are some of the devastating side effects of a common female disorder called Polycystic Ovary Syndrome (PCOS). PCOS affects between 3 and 5 percent of women of reproductive age. Although doctors identified the disease in the 1930s, the exact cause remains elusive. Recently doctors have noticed a frightening new trend among PCOS patients. Most have high insulin levels, making them more prone to developing type II diabetes and diabetes-related health problems. The disease could also lead to other serious side effects, including high blood pressure, high cholesterol levels, heart disease and endometrial cancer.

Researchers in the departments of medicine/diabetes, obstetrics and gynecology (ob-gyn), plastic and reconstructive surgery and the Research Imaging Center at The University of Texas Health Science Center at San Antonio are conducting a study to find the cause of PCOS and treatment for its symptoms.

“This is the first time that PCOS has been looked at with such a wide perspective,” said Rachele Berria, M.D., research fellow in the department of medicine/diabetes. Dr. Berria, along with Ralph DeFronzo, M.D., professor and chief of the division of medicine/diabetes, are the principal investigators. They are collaborating with Robert Brzyski, M.D., Ph.D., associate professor of ob-gyn; Scott Lucidi, M.D., assistant instructor of ob-gyn; and Douglas Cromack, M.D., chief of the division of plastic and reconstructive surgery at the Health Science Center. Researchers in the department of molecular medicine at Northwestern University in Chicago are also involved in the project.

“Doctors wonder whether the drug pioglitazone, used to treat patients with type II diabetes, could help alleviate some of the symptoms of PCOS,” Dr. Berria said. “However, more information is needed to determine what exactly causes PCOS, what the mechanisms are through which pioglitazone works, and whether other treatment methods can be used to supplement the positive effects of pioglitazone,” she said.

For women who suffer from PCOS, a cure could mean relief from unwanted hair growth and acne. More importantly, it could mean protection from diabetes, heart disease and endometrial cancer. For women who are infertile, a cure for PCOS could mean the ability to become pregnant in the future.

Health Science Center researchers welcome study participants. Women who have PCOS are encouraged to sign up for the study. Women between the ages of 18 and 40, with a Body Mass Index of 35 or less, who are not on hormone therapy, including birth control, are eligible. Participants will be asked to undergo a series of diabetes tests, sonograms, MRIs, and tissue biopsies, and will be given pioglitazone for a period of four months. Participants will earn $600 after the study is completed.

For more information or to sign up for the study, call Irma Guerra, research coordinator, at (210) 567-4773.

Only 2 months left to enroll in STAR breast cancer prevention study

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San Antonio (March 23, 2004) – Most of us know someone, perhaps even a close loved one, who has had breast cancer. Nearly 200,000 American women a year are diagnosed with the disease and 40,000 deaths are linked to it. Breast cancer is the most common cancer in women.

Women who want to decrease their chances of developing the disease are invited to inquire about eligibility for the STAR breast cancer prevention trial (STAR is short for the Study of Tamoxifen and Raloxifen). More than 18,000 women are participating in the study at 500 sites across the United States through the National Surgical Adjuvant Breast and Bowel Program, a network of researchers supported by the National Cancer Institute. The University of Texas Health Science Center at San Antonio, a participating center since 1999, is offering a final opportunity for patients to enroll in the study through May 20, when enrollment will end.

“We seek to enroll postmenopausal women age 35 or older who are at increased risk for breast cancer because of factors such as present age, number of first-degree female relatives with breast cancer and history of previous breast biopsies,” said Morton S. Kahlenberg, M.D., principal investigator of the trial and associate professor of surgery at the Health Science Center. “Women will benefit by obtaining preventive medications at no cost while taking part in a study that will, No. 1, determine which medication is better in the long run at preventing breast cancer and, No. 2, compare the long-term safety of the two therapies.” An added benefit will be close medical observation throughout the study, resulting in earlier detection of disease should it develop.

Women will be randomized to one of the two treatment arms. STAR participants take the daily dose of either tamoxifen or raloxifen for five years and are followed for two more years after discontinuation of the study medication. After an initial visit to the Health Science Center, all tests and evaluations can be performed by the woman’s own physician.

At least 100 women are needed locally to participate. For more information, call Betty Razvillas, research nurse, at (210) 567-5755 or Mireya Vasquez, data manager, at 567-5759.

Inhalants cause blindness, other problems, poison specialists say

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PoisonControl_BODYSan Antonio (March 19, 2004) – Three young people in South Texas are permanently blind because they sniffed carburetor cleaners – another strong reminder of the serious dangers of getting high off these inhalants, said a specialist from the South Texas Poison Center at The University of Texas Health Science Center at San Antonio.

As National Inhalants and Poisons Prevention Awareness Week rolls around March 21-27, the need for education, especially among young people, has never been greater. “Last year we had three people who went blind as a result of methanol exposure, specifically to carburetor cleaners,” said Cindy Teter, Pharm.D., certified specialist in poison information at the South Texas Poison Center. “These individuals are in their 20s and 30s. They told us they had been sniffing it for years. This vision loss is irreversible – once it happens you don’t get it back.”

These inhalants also may damage the heart, liver and central nervous system.

Dr. Teter and Leslie DeHart, R.N., are studying the Poison Center’s case files on methanol inhalant poisonings in 2002 and 2003, including one report of poisoning in a 12-year-old. “We started writing an article after seeing this and hope to publish it in an academic journal in the field of toxicology,” DeHart said. “It used to be thought that people wouldn’t end up with high methanol levels and the blindness that goes with it. We thought it was unusual to have three people with vision loss.”

The Poison Center is a free and confidential public service offered 24 hours a day, seven days a week at 1-800-222-1222. The center handled 36 methanol-related calls in 2002 and 2003 and many more involving other inhalants. In 2002, 116 intentional inhalation exposures (all ages and all substances) were reported to the Poison Center. In 2003, 112 were reported.

Carburetor cleaners are particularly toxic. “It’s a cheap way to get high, but I don’t think people realize they can get blindness by huffing methanol,” Dr. Teter said. “Some products contain toluene, which basically kills your brain cells.”

All the methanol cases were in the South Texas Poison Center’s 47-county calling area. Eighteen subjects required aggressive therapy with antidote treatment, dialysis to help eliminate the chemicals from the body, and even intubation or mechanical ventilation. “It can cause some significant symptoms, and that’s the main thing we need to get across to people,” DeHart said.

All of the cases were reported from hospitals where the individuals had been taken and where hospital staff called the Poison Center for consultation. “We get calls from people at home, from Emergency Medical Services so we can give suggestions en route to hospitals and from health care professionals in emergency settings,” DeHart said. “We give a recommendation depending on the exposure.”

The trained personnel manning the phones at the Poison Center are registered nurses, pharmacists or physicians. The Poison Center’s medical director, Miguel C. Fernández, M.D., associate professor of surgery at the Health Science Center, is an emergency medicine physician who is board certified in toxicology.

Dr. Teter urged parents, guardians and mentors to talk to children and teenagers about the dangers of inhalant abuse

S.A. among 12 sites for TODAY trial to test medicines, lifestyle changes in young

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San Antonio (March 16, 2004) – “I didn’t take care of myself as I should have, so I push her and push her and I’m never going to stop.”

Juanita Aleman, who at the young age of 39 lives with severe complications of type 2 diabetes, said the words within earshot of her 15-year-old daughter, Marie. Marie helps care for her mother at their home on Southwest 39th Street, where Juanita is the best real-life teacher about diabetes that Marie could ever have. That’s important, because Marie already is on insulin and medication to control her own blood sugar.

Marie and Juanita represent the urgent need for clinical studies such as the five-year TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) trial. Faculty and staff from The University of Texas Health Science Center at San Antonio and medical staff of the University Health System treat patients at the TDI, which is in the University Center for Community Health at 701 S. Zarzamora.

The TDI is one of 12 sites nationwide selected to recruit children ages 10 to 17 into the TODAY study for the purpose of comparing three treatments for type 2 diabetes – metformin alone, metformin and rosiglitazone together, and metformin plus intensive lifestyle change to lose weight and increase exercise.

The San Antonio investigators seek to enroll more than 60 young people who have been diagnosed with type 2 diabetes in the last two years, including many from Hispanic and African-American families in Bexar and surrounding counties.

Study-related medical care and medications are provided at no cost. A $3 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases supports the San Antonio site. For more information about the TODAY study, call toll-free 1-866-764-6450.

“The TDI, the largest center focusing solely on diabetes in the country, is the perfect place to recruit the children and teens who will benefit from this important clinical study,” said local Principal Investigator Daniel Hale, M.D., professor of pediatrics and chief of the division of pediatric endocrinology and diabetes at the Health Science Center and pediatric medical director at the TDI. “We need to know which medications will best help our precious patients such as Marie.”

For Juanita, the relatively new medications came along a decade too late. She is blind and undergoes renal dialysis three times a week. The first clues to the awful nature of the disease came in 1992, three years after she gave birth to Marie. She was at work in a restaurant and burned her foot. “I lost a toe. That’s when I found out my diabetes was beginning to worsen.”

Juanita had developed gestational diabetes while pregnant with both Marie and her older sister, Genevieve. But she was a working single mother and didn’t have much time to devote to monitoring her diabetes and making changes.

After 2000 her vision began to deteriorate, first in the right eye, then in the left. Within five months, her sight was gone. “It was scary because I had two teenagers,” Juanita said. “Thank God I’ve got two young ladies who have done well in school.”

A year ago, she took her physician’s advice and went on dialysis. “I didn’t want to, but I was getting pneumonia frequently,” she explained, noting that the clearance of the body’s toxins from her kidneys has made a huge difference in her energy level.

In diabetes, the body has difficulty regulating blood glucose and converting it to energy. Type 2 diabetes involves resistance to insulin, a substance secreted by the pancreas. Insulin converts blood glucose into energy. Over time, insulin production weakens, potentially leading to harmful changes in the eyes, kidneys, heart, nerves and blood vessels. The TODAY study is a response to the alarming increase of type 2 diabetes among children and teens, particularly among Hispanics, African Americans and American Indians.

Marie’s blood sugar readings were running 400 last year (normal is 85 to 125) and the busy teenager was using her blood glucose monitor as seldom as once a week. Now she’s testing herself three times a day. “She’s come a long way,” said Ruby Favela-Prezas, BSN, RN, a nurse who counsels Marie at the TDI Children’s Center.

“All teens, if they try hard, can do it, but it’s a lot of stress for a teenager,” Juanita said. “Ruby is a like a big sister doing a lot of coaching and convincing.”

Marie has learned to shop for more nutritious food such as vegetables and lean meats and to prepare healthy meals at home. She wants to be a nurse or a chef. She said a friend at school “drinks nothing but soda and I get mad at her.”

Marie even gets mad at herself for occasionally having high blood sugar. “It’s not your fault,” Ruby said to her. “Being a Latin American, you have a higher risk of developing diabetes.”

Marie has a much better chance to beat the complications of diabetes than her mother did. She helps out at home and continues to learn about type 2 diabetes. “If I had a plaque, I’d give her the biggest plaque for the year,” Juanita said, causing tears in Marie’s eyes. “I would pull down a star for her.”

Health Science Center researchers attract record $189 million

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San Antonio (March 16, 2004) – The University of Texas Health Science Center at San Antonio pulled in by far the largest amount of research funding of any South Texas university or institution in fiscal 2003, garnering a record $189 million in competitive awards for research and related activities. That’s a healthy increase of 20 percent over fiscal 2002.

The banner research year included a $37 million grant to study small subcortical strokes, the most common strokes in South Texas. The five-year study, funded by the National Institutes of Health (NIH), is the largest single research grant in the Health Science Center’s history.

Grants, contracts and awards, both federal and non-federal, soared above the fiscal 2002 total of $157 million. The stroke study alone will bring more grant funding to South Texas than the current annual sponsored research of any other university in San Antonio or the region.

“For every research dollar that comes to South Texas, five dollars are generated for the economy in the form of new jobs, products and services,” Health Science Center President Francisco G. Cigarroa, M.D., said. “Using this multiplier, the Health Science Center’s research enterprise has nearly a billion-dollar impact on the South Texas economy.”

Since fiscal 1999, the amount of NIH grants and contracts to the Health Science Center has risen from $45.9 million to $82.7 million, an outstanding increase of 80 percent.

The largest Health Science Center competitive awards in recent months are to Oscar Benavente, M.D., department of medicine, $37 million to study stroke; Ralph DeFronzo, M.D., medicine, $7.4 million to study diabetes; Tom Patterson, M.D., medicine, $7.1 million to study a life-threatening infection called invasive aspergillosis; H. Ralph Rawls, D.D.S., restorative dentistry, $5.9 million to develop advanced dental restorative systems; Hanna Abboud, M.D., medicine, $4.3 million to study mechanisms of kidney injury; and Kenneth Hargreaves, D.D.S., Ph.D., endodontics, $3.6 million to study mechanisms of opioid analgesia (pain relief).

Since 1972, the Health Science Center has expended nearly $6 billion with an estimated impact on the South Texas economy of nearly $30 billion.

Health Science Center celebrates lifesaving device’s FDA approval

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San Antonio (March 16, 2004) – The University of Texas Health Science Center at San Antonio is proud to have assisted in the development of the EZ-IO™ system for infusing medications, blood and fluids in emergency situations, Health Science Center President Francisco G. Cigarroa, M.D., said today.

Dr. Cigarroa responded to the news that the device’s maker, VidaCare™ Corp. of San Antonio, had received 510(k) clearance from the U.S. Food and Drug Administration to market the infusion system. The EZ-IO™, which allows intraosseous access through the bone marrow cavity, is expected to provide a viable alternative to traditional intravenous (IV) access, which often is difficult to start in patients whose veins have collapsed because of trauma.

“FDA approval is a major achievement,” said Dr. Cigarroa, a noted pediatric and transplant surgeon. “This innovation will save many lives and could become the standard of care in emergency medicine. We congratulate our colleagues at VidaCare™.”

“FDA approval confirms our sense that the device is both safe and effective for the proposed uses,” said Harold L. Timboe, M.D., associate vice president for administration at the Health Science Center and a member of the VidaCare™ Board of Directors.

Dr. Timboe, former commanding general of Brooke Army Medical Center in San Antonio and Walter Reed Army Medical Center in Washington, D.C., said the device combines straightforward science and existing technology, “resulting in potentially many lives saved in challenging circumstances – from paramedics coming upon an accident scene to battlefield casualty care to emergency departments in the hospital setting.”

The EZ-IO™ provides rapid and reliable access to the bone marrow cavity in about nine seconds through a hand-held, battery-powered drill. It is expected to assist some of the 12 million patients a year for whom starting an IV line is difficult and time-consuming.

The Health Science Center holds 6 percent equity in VidaCare™, which means if the company is sold and there is no dilution of ownership, the Health Science Center will derive 6 percent of the acquisition price. Alan Dean, director of the Office of Technology Ventures at the Health Science Center, credited Steven A. Wartman, M.D., Ph.D., executive vice president for academic and health affairs, with “giving us the freedom to construct what was then a unique licensing arrangement for this Health Science Center.” VidaCare™ has multiple patents to protect this platform technology from competition in the marketplace, Dean said.

The Health Science Center provided support and consultation during the product’s development, including protocols utilizing its laboratory animal resources department.

“It’s a great day for us and a great day for the Health Science Center, which has been a very supportive partner throughout the development of this device,” said VidaCare™ CEO Larry Miller, M.D. “I want to thank Drs. Cigarroa and Wartman for their understanding of a start-up company and what it takes to make this a success in the marketplace. This is an investment that should result in a significant benefit to the critically ill and injured in this country and on the world’s battlefields.”

VidaCare™ plans to market the EZ-IO™ in the United States, Canada and Europe. It will conduct marketing trials in about 20 U.S. centers and expects to roll out the product in June.