For type 2 diabetics who are not on insulin, monitoring their blood sugar does little to control blood sugar levels over time and may not be worth the effort or expense, according to a new evidence review.

Self-monitoring blood sugar levels for type 1 diabetics and type 2 diabetics who require insulin is recognized as a critical part of self-care.

For these insulin taking diabetics, keeping track of blood sugar levels helps them attempt to keep glucose levels within an acceptable range.

However, it has been unclear if self-monitoring of blood sugar has the same value for type 2 diabetics who are not on insulin.

To answer this question, Uriëll L. Malanda of the VU University Medical Center in Amsterdam and his colleagues reviewed 12 studies, of more than 3,000 non-insulin-using diabetics.

The review showed that self-monitoring of blood sugar by these patients had only a modest effect on a measure called HbA1c, a standard for assessing blood glucose control.

Over a six-month period, patients who tested their own blood glucose levels reduced HbA1c by about 0.3 percent. This effect nearly completely dissipated after 12 months.

Key Points:

• In patients with diabetes who don’t require insulin, self-monitoring of blood glucose had a modest effect on HbA1c levels at six-months, which subsided after 12 months.

• Self-monitoring of blood glucose in non-insulin treated diabetics had no effect on satisfaction, general well-being or general health-related quality of life.

• Supplies required for self-monitoring of blood glucose are more expensive than for urine testing, a common alternative for non-insulin treated diabetics.

Additionally, the review showed that blood sugar self-monitoring had no effect on patients’ satisfaction, general well being, or general health-related quality of life.

One study, which compared the cost of the first year of monitoring blood for glucose versus urine testing, found that monitoring blood glucose was 12 times more expensive.

Mayer Davidson, M.D., a professor of medicine at Charles Drew University in Los Angeles who authored one of the studies included in the review, notes that many endocrinologists recommend blood glucose self-monitoring as part of efforts to educate patients on the effect of lifestyle habits—for example, how eating an apple affects their blood glucose compared to drinking a glass of apple juice. However, knowing their blood sugar numbers doesn’t appear to change patients’ behavior.

“Patients aren’t using these numbers to do anything clinically significant,” he says.

With the cost of blood glucose test strips for home monitoring equipment hovering around 1 dollar apiece, he adds, there doesn’t appear to be enough “bang for the buck” to recommend that form of self-monitoring for most patients.

Authors of the review agree. “Regular self-monitoring of blood glucose in non-insulin treated patients has minimal impact on glycemic control, has no impact on general well-being or quality of life, and is rather expensive. Consequently, it does not add to a clinically relevant long-term benefit,” Malanda says.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

The report, America’s Health Rankings, is published jointly by United Health Foundation, American Public Health Association and Partnership for Prevention.

Top-ranked states:

1. Vermont
2. New Hampshire
3. Connecticut
4. Hawaii
5. Massachusetts

Bottom-ranked states:

Washington State Trends:

Among the trends that drove down Washington State’s rankings this year were rises in the rates of obesity, diabetes, and smoking and a decline in high school graduation rates.

The annual study, America’s Health Rankings, assesses a state’s health using not only standard measures of health, such as infant mortality rates, but also by such measures as smoking, obesity, and high school graduation rates — all of which provide indications of a population’s overall health status.

High school graduation rates are considered in the ranking because, in general, graduates tend to go on to have fewer health problems later in life.

Among the trends in Washingtion the report found troubling were:

• A marked increase in obesity rates among the state’s residents over the past decade from 18.8 percent to 26.2 percent, meaning that 1.6 million of Washington state’s adults are now obese.

• A steady increase in the the rate of diabetes, which rose from 6.3 percent five years to 7.3 percent in 2011, meaning that 391,000 adults in the state now have the disease.

• And a decline in the number of students graduating from high school in four years to the lowest rate in seven years, 71.9 percent, placing the state 38th in the nation for high school graduation.

Other challenges facing the state identified by the report were a low immunization rate among children, 88.6 percent. That rate makes the state 39th in the nation.

National progress stagnates

The report found that the nation made no progress in improving its overall health this year with modest improvements being offset by a number of troubling trends.

Among improvements were declines in smoking, cardiovascular deaths and preventable hospitalizations:

• Smoking cessation: 17.3 percent of the population smoked in 2011, down from 17.9 percent in 2010 – a 3.4 percent decline since 2010; a 25.4 percent decline since 2001.

• Cardiovascular deaths: 270.4 deaths per 100,000 in 2011, down from 278.2 deaths per 100,000 in 2010 – a 2.8 percent decline since 2010; a 22.2 percent decline since 2001.

• Preventable hospitalizations: 68.2 preventable hospitalizations per 1,000 Medicare enrollees in 2011, down from 70.6 preventable hospitalizations in 2010 – a 3.4 percent decline since 2010; a 17.3 percent decline since 2001.

By Michelle Andrews

Jackie Risley, before and after her bariatric surgery (Photos provided by Risley)

As obesity among young people continues to rise, a growing number of clinicians and researchers say that weight-loss surgery may be their best chance to take off significant weight and either correct or avoid conditions like diabetes and heart disease, which often go hand-in-hand with obesity.

But although health plans frequently cover bariatric surgery in adults, insurance coverage for the procedure in patients under age 18 is spotty.

Experts in pediatric obesity say that caution is warranted and that insurers shouldn’t just rubber-stamp such surgery in adolescents.

But they say emerging research may lead to more coverage for young people.

Anyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals.

And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices.

These include HCG weight-loss products marketed over-the-counter (OTC) that are identified as “homeopathic” and direct users to follow a severely restrictive diet.

The Food and Drug Administration (FDA) is advising consumers to steer clear of these “homeopathic” human chorionic gonadotropin (HCG) weight-loss products.  They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores.

FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that make unsupported claims.

(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visit www.fda.gov/hcgdiet.)

HCG Makes Big Claims

HCG is a hormone that is produced by the human placenta during pregnancy.

Products that claim to contain HCG are typically marketed in connection with a very low calorie diet, usually one that limits calories to 500 per day.

Many of these popular HCG products claim to “reset your metabolism,” change “abnormal eating patterns,” and shave 20-30 pounds in 30-40 days.

“These products are marketed with incredible claims and people think that if they’re losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG.”

HCG is approved by FDA as a prescription drug for the treatment of female infertility, and other medical conditions. It is not approved for weight loss.

In fact, the prescription drug label notes there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

HCG is not approved for OTC sale for any purpose.

A Potentially Dangerous Diet

Living on 500 calories a day is not only unhealthy—it’s hazardous, according to FDA experts. Consumers on such restrictive diets are at increased risk for side effects that include gallstone formation, an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, and an irregular heartbeat.

Shirley Blakely, a nutritionist at FDA’s Center for Food Safety and Applied Nutrition, echoes concerns about such restrictive diets. They can be dangerous, she says, and potentially fatal.

Very low calorie diets are sometimes prescribed by health care professionals for people who are moderately to extremely obese as part of medical treatment to lessen health conditions caused by obesity, like high blood pressure.

But even then, strict—and constant—medical supervision is needed to ensure that side effects are not life threatening, says Blakely.

Without medical oversight, consumers on very low calorie diets may not be getting enough vitamins, minerals and—most critically—protein.

“In general, the reference (average) calorie level is 2,000,” says Blakely. “If you want to lose weight, reduce your daily intake by 500 calories. Over the course of a week, that equals 3500 calories, which is the loss of a pound. Gradual weight loss is the way to do it.

Story Started Decades Ago

Miller explains that HCG was first promoted for weight loss in the 1950s. “It faded in the 1970s, especially when it became apparent that there was a lack of evidence to support the use of HCG for weight loss,” she says.

The diet has become popular again and FDA and FTC are taking action on illegal HCG products. “You cannot sell products claiming to contain HCG as an OTC drug product. It’s illegal,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch. “If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution.”

Elisabeth Walther, a pharmacist at FDA, explains that the agency does not evaluate homeopathic drug products for safety or effectiveness, and is not aware of any scientific evidence that supports homeopathy as effective.

However, those that meet certain conditions set by FDA can be marketed. A reference document called the Homeopathic Pharmacopoeia of the United States lists active ingredients that may be legally included in homeopathic drug products.

“HCG is not on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.

FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions. Harmful effects should be reported online to FDA’s MedWatch program or by phone at 800-FDA-1088 (800-332-1088) and to the consumer’s health care professional.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 6, 2011

Uncovering the Mechanisms Linking Obesity and Cancer Risk

By Sharon Reynolds
NCI Cancer Bulletin Staff Writer 

Being overweight or obese is associated with an increased risk for many types of cancer, including postmenopausal breast cancer; endometrial cancer; and colorectal, esophageal, gallbladder, kidney, pancreatic, and thyroid cancer.

These risks are not minor. In 2002, the International Agency for Research on Cancer, using European data, estimated that obesity contributed to more than one-third of endometrial and esophageal cancer cases and a quarter of kidney cancer cases. (See the table below.)

Being overweight or obese also raises the risk of dying of cancer. In an often-cited paper published in 2003 in the New England Journal of Medicine, researchers from the American Cancer Society estimated that 14 percent of all cancer deaths in men and 20 percent in women could be blamed on excess weight.

The obvious question is: Why? What biological processes mediate the relationship between excess body fat and increased cancer risk? Researchers are only beginning to tease out the answers, but almost all the factors under study are rooted in the fact that adipose (fat storage) tissue is highly metabolically active.

Once thought to be just a passive storage depot for fuel, adipose tissue is now known to pump out an astounding array of hormones, growth factors, and signaling molecules, all of which can influence the behavior of other cells in the body.

Excess Hormones, Extra Risk

Most, if not all, of the molecules being studied as potential mediators between obesity and cancer are not cancer-causing but cancer-promoting. That is, they do not cause the mutations that turn a normal cell into a cancerous cell, but instead feed the growth and proliferation of malignant cells.

One of the best understood of the pathways that may lead from obesity to cancer involves the hormone estrogen, which fuels a large number of breast and endometrial cancers. In postmenopausal women, the levels of estrogen circulating in the bloodstream normally drop drastically, as the ovaries stop producing the hormone.

But fat tissue also produces estrogen, through a cellular pathway involving the enzyme aromatase, the target of several breast cancer therapies called aromatase inhibitors.

In obese women, “the body fat just becomes an estrogen-producing machine,” explained Dr. Leslie Bernstein, director of the Division of Cancer Etiology at City of Hope Comprehensive Cancer Center, who has studied the relationship between estrogen and cancer risk for years through the California Teachers Study.

This excess estrogen produced by fat can feed cancer cells that express the estrogen receptor. But estrogen alone does not account for all of the extra risk for these cancers in obese postmenopausal women.

Another likely player in many types of cancer, including breast, colorectal, and pancreatic cancer, is insulin, the hormone that triggers cells in the body to take up glucose (sugar) from the bloodstream.

Adipose Tissue

Obesity often goes hand in hand with metabolic syndrome and type II diabetes. In type II diabetes, the body’s cells stop responding to insulin, causing a buildup of glucose in the blood, which in turn stimulates the body to produce even more insulin.

And in some cancers, “insulin acts as a mitogen—it makes cancers grow faster,” said Dr. Michael Pollak, director of the Division of Cancer Prevention at McGill University in Montreal.

Interestingly, a diabetes drug called metformin, which lowers the levels of blood glucose, has shown some anticancer activity. Several studies have suggested that people with diabetes who took metformin had a lower risk of developing cancer ordying from the disease compared with diabetics who did not take metformin.

Currently, several clinical trials, including one in breast cancer, are testing the addition of metformin to standard treatment.

It will be important, stressed Dr. Pollak, to continue basic science research on metformin, given the many unanswered questions about who should take the drug.

“I think this is an extremely promising area of cancer research, but we need to do more basic science research before we’ll be able to design the best clinical trials” to figure out which patients are most likely to benefit from the drug, he said.

For example, other diabetes drugs lower insulin levels but don’t show a similar anticancer effect, suggesting that metformin may affect more than just the insulin pathway.

Also, some patients’ tumors have mutations in the insulin signaling pathway that make the cells act as if extra insulin is always present, even when it’s not. In these cases, reducing insulin would be futile in terms of cancer control. “So maybe those patients shouldn’t be on clinical trials of metformin,” said Dr. Pollak.

Digging Deeper

A myriad of other molecules are being studied to see if they contribute to the relationship between obesity and cancer. Some of these molecules, such as certain interleukins, are part of the body’s natural inflammatory response, which is often chronically overstimulated in people who are obese.

Others are signaling molecules called adipokines (cytokines produced by fat tissue), levels of which can be affected by weight gain.

Within NCI, researchers in the Division of Cancer Epidemiology and Genetics (DCEG) are using several multimarker panels to study molecular pathways that may link obesity to cancer risk in humans. Two panels—one that assesses 15 different estrogens and estrogen metabolites, and one that assesses 79 molecular markers of inflammation—are already being used to examine these mechanisms.

A third, more experimental panel simultaneously tests 400 to 600 small molecules to give a snapshot of metabolism at the time of sample collection, said Dr. Steve Moore, a research fellow in DCEG’s Nutrition Epidemiology Branch.

With these panels, “you can look at how the markers are related to cancer risk, you can look at how obesity is related to cancer risk, and you can look at how obesity is related to cancer risk after adjusting for the marker levels,” explained Dr. Moore. “So by triangulating these three things, you can estimate which molecular mechanisms obesity is most likely to act through.”

Other researchers are examining genetic variants that might also influence how obesity and cancer risk intersect. “A lot of people have looked at biomarkers like insulin, but what are the [full] genetic and molecular pathways being affected by obesity?” asked Dr. Li Li, associate director for Prevention Research at Case Comprehensive Cancer Center, Case Western Reserve University.

His project, supported by the first tranche ofTransdisciplinary Research on Energetics and Cancer (TREC) funding, is looking at how genetic variants found naturally in the population influence whether obesity can promote colon polyp formation.

All of this research may eventually help create targeted cancer prevention measures and treatments for overweight and obese patients, based on a better understanding of the molecular events driving progression.

For now, “I would say what we know now supports the adoption of a healthier lifestyle that promotes weight control,” concluded Dr. Moore.

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.