FDA Approves Device To Treat Obesity

Recently, the U.S. Food and Drug Administration approved the very first weight loss device that controls satiety.  The Maestro Rechargeable System targets the neural pathway between the brain and the stomach that controls feelings of hunger and fullness.

However, this device will only be available to adults aged 18 years of age and older with a body mass index of 35-45 combined with at least one other obesity-related condition (i.e. type 2 diabetes) that have had no success with weight loss programs.

How does it work?

“The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.”

In addition, health care professionals will have the ability to adjust settings on this surgically implanted device as required throughout treatment.

Is it safe?

A clinical trial consisting of 233 patients with a BMI of 35+ were tested over a period of 12 months to ensure the product is safe and effective.  The Maestro Rechargeable System was tested on all patients however, 76 of the devices were not activated. Results showed that those with the activated devices lost 8.5% more weight than those with inactive devices.  Remarkably, fifty-two and a half percent of the patients with the active device experienced a 20% weight loss and 38.3% lost 25% of their excess weight.

However, both groups experienced a weight loss.  In fact, participants with the active devices did not even lose at least 10% more than those with inactive devices.  In addition, reported side effects included nausea, pain at the neuroregulator site, vomiting, surgical complications, pain, heartburn, problems swallowing, belching, mild nausea and chest pain.

Despite these results, the FDA determined that the benefits outweigh any risk to a patient that meets the eligibility criteria.  An FDA-sponsored survey also indicated that individuals would be willing to use this device based on the presumed weight loss.  Still, the FDA requires that the manufacturer conduct a five year follow up study of a minimum of 100 patients to further review the device’s safety and effectiveness.

Facts on obesity:

• During the past 20 years, there has been a dramatic increase in obesity in the United States and rates remain high.
  
• More than one-third (34.9% or 78.6 million) of U.S. adults are obese.
  
• Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death.
  
• The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars; the medical costs for people who are obese were $1,429 higher than those of normal weight.

FDA approves first-of-kind device to treat obesity
Centers for Disease Control and Prevention

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More Than Two Drinks Per Day Can Increase Your Risk of Stroke

According to a new study, drinking more than 2 alcoholic drinks each day in middle-age increases a person’s risk of stroke more than typical risk factors such as high blood pressure and diabetes.

Researchers used data gathered between 1967 and 2010 from 11,644 individuals from the Swedish Twin Registry to compare the effects of heavy drinking on risk of stroke. Heavy drinking was defined as 2 or more drinks per day and light drinking as less than 0.5 drinks per day.  

Results demonstrated that heavy drinking increased the risk of stroke by 34% in comparison to light drinking.  The heavy drinkers were also more likely to have a stroke 5 years earlier than their counterparts, regardless of genetics or other factors.  In addition, middle-aged heavy drinkers exhibited a risk of stroke comparable to individuals with high blood pressure and diabetes.  Moreover, the study found that almost 30% of participants had suffered a stroke and by age 75, blood pressure and diabetes were regarded as the main cause of stroke. 

“Among identical twin pairs, siblings who had a stroke drank more than their siblings who hadn't had a stroke, suggesting that mid-life drinking raises stroke risks regardless of genetics and early lifestyle.”

Not only does regular heavy drinking increase the risk of stroke, it also affects blood pressure and causes various health complications.  

Effects of Alcohol:

Drinking too much – on a single occasion or over time – can take a serious toll on your health.  Here’s how alcohol can affect your body:

Heart: Drinking a lot over a long time or too much on a single occasion can damage the heart, causing problems including:

• Cardiomyopathy – Stretching and drooping of heart muscle
• Arrhythmias – Irregular heart beat
• Stroke
• High blood pressure  

* Research also shows that drinking moderate amounts of alcohol may protect healthy adults from developing coronary heart disease.

Liver: Heavy drinking takes a toll on the liver, and can lead to a variety of problems and liver inflammations including:

• Steatosis, or fatty liver
• Alcoholic hepatitis
• Fibrosis
• Cirrhosis

Pancreas: Alcohol causes the pancreas to produce toxic substances that can eventually lead to pancreatitis, a dangerous inflammation and swelling of the blood vessels in the pancreas that prevents proper digestion. 

Cancer: Drinking too much alcohol can increase your risk of developing certain cancers, including cancers of the:

• Mouth
• Esophagus
• Throat
• Liver
• Breast

Immune System: Drinking too much can weaken your immune system, making your body a much easier target for disease.  Chronic drinkers are more liable to contract diseases like pneumonia and tuberculosis than people who do not drink too much.  Drinking a lot on a single occasion slows your body’s ability to ward off infections – even up to 24 hours after getting drunk.

Brain: Alcohol interferes with the brain’s communication pathways, and can affect the way the brain looks and works. These disruptions can change mood and behavior, and make it harder to think clearly and move with coordination.  

People who have been drinking large amounts of alcohol for long periods of time run the risk of developing serious and persistent changes in the brain. Damage may be a result of the direct effects of alcohol on the brain or may result indirectly, from a poor general health status or from severe liver disease.

Up to 80 percent of alcoholics, however, have a deficiency in thiamine, and some of these people will go on to develop serious brain disorders such as Wernicke–Korsakoff syndrome (WKS).  WKS is a disease that consists of two separate syndromes, a short–lived and severe condition called Wernicke’s encephalopathy and a long–lasting and debilitating condition known as Korsakoff’s psychosis.

The symptoms of Wernicke’s encephalopathy include mental confusion, paralysis of the nerves that move the eyes (i.e., oculomotor disturbances), and difficulty with muscle coordination. For example, patients with Wernicke’s encephalopathy may be too confused to find their way out of a room or may not even be able to walk. 

Approximately 80 to 90 percent of alcoholics with Wernicke’s encephalopathy also develop Korsakoff’s psychosis, a chronic and debilitating syndrome characterized by persistent learning and memory problems. Patients with Korsakoff’s psychosis are forgetful and quickly frustrated and have difficulty with walking and coordination. Although these patients have problems remembering old information (i.e., retrograde amnesia), it is their difficulty in “laying down” new information (i.e., anterograde amnesia) that is the most striking. 

Heavy drinking in middle-age may increase stroke risk more than traditional factors
National Institute on Alcohol Abuse and Alcoholism

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Diabetic Medication Helps Improve Memory

Researchers at the University of Texas Medical Branch at Galveston revealed that an FDA-approved medication called rosiglitazone that is used to treat insulin resistance in diabetics also enhances learning and memory. This discovery could improve cognitive performance for those with Alzheimer’s disease.

By studying genetically engineered mice designed to serve as models for Alzheimer's, “the scientists believe that the drug produced the response by reducing the negative influence of Alzheimer's on the behavior of a key brain-signaling molecule.”

The molecule in question is called extracellular signal-regulated kinase (ERK). In the brains of Alzheimer's patients as well as the mice in the study, this molecule becomes hyperactive, which leads to improper synaptic transmission between neurons thereby interfering with learning and memory.

“Rosiglitazone brings ERK back into line by activating what's known as the peroxisome proliferator-activated receptor gamma (PPARγ) pathway, which interacts with genes that respond to both PPARγ and ERK.”

Basically, the medication helps to restore signals between neurons so that cognitive functions become more normal. This research opens a gateway allowing researchers to test more FDA-approved drugs to try and normalize insulin resistance in Alzheimer's patients while potentially improving their memory at the same time. It could also lead to a greater understanding of the biology behind the cognitive issues in Alzheimer's disease.

Alzheimer's disease (AD) is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death.

Symptoms:

• Memory loss that disrupts daily life.
• Challenges in planning or solving problems.
• Difficulty completing familiar tasks at home, at work or at leisure.
• Confusion with time or place.
• Trouble understanding visual images and spatial relationships.
• New problems with words in speaking or writing.
• Misplacing things and losing the ability to retrace steps.
• Decreased or poor judgment.
• Withdrawal from work or social activities.
• Changes in mood and personality.

Prevalence:

• An estimated 5.4 million Americans of all ages have Alzheimer’s disease in 2012. This figure includes 5.2 million people age 65 and older and 200,000 individuals under age 65 who have younger-onset Alzheimer’s.
• One in eight people age 65 and older (13 percent) has Alzheimer’s disease.
• Nearly half of people age 85 and older (45 percent) have Alzheimer’s disease.
• Of those with Alzheimer’s disease…
• an estimated 4 percent are under age 65
• 6 percent are 65 to 74
• 44 percent are 75 to 84
• 46 percent are 85 or older
• Every 68 seconds, someone in America develops Alzheimer’s.
• By mid-century, someone in America will develop the disease every 33 seconds.

Diabetes Drug Improves Memory, Study Suggests
Alzheimer's disease
Facts and Figures facts and figures

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Early Emotional Neglect May Predict Strokes

New research conducted by the Rush Alzheimer's Disease Center at Rush University Medical Center suggests that emotionally neglected children are at risk of stroke as adults. 

"Studies have shown that children who were neglected emotionally in childhood are at an increased risk of a slew of psychiatric disorders. However, our study is one of few that looked at an association between emotional neglect and stroke," said study author Robert S. Wilson, PhD, a neuropsychologist at Rush.

Researchers’ selected 1,040 participants aged 55+ without dementia from the Memory and Aging Project were surveyed on physical and emotional abuse before the age of 18. Participants were questioned on such areas as how much love they felt from their parents or caregivers as children, whether they felt afraid or intimidated by their caregivers, the method of physical punishment suffered and other questions relating to divorce and family finances.

The participants were followed over a period of 3.5 years. In that time, 257 participants had died. Of the deceased participants, only 192 had brain autopsies, which revealed that 89 of them had experienced strokes. Furthermore, forty of the participants were said to have had strokes based on medical history or an examination.

Furthermore, participants that expressed moderately high levels of emotional neglect in childhood were nearly 3 times more likely to experience a stroke than those reporting moderately low levels of emotional childhood neglect, even when other factors such as diabetes, physical activity, smoking, anxiety and heart problems were controlled.

"The results add to a growing body of evidence suggesting that early life factors such as traumatic childhood experiences influence the development of physical illness and common chronic conditions of old age" says Dr. David A. Bennett, director of the Rush Alzheimer's Disease Center and co-author of the study

Of course results may not be completely reliable since this study relies on a self-report of recalled events many years later, which may be even further clouded given the nature of the potentially traumatic memories.

Emotional Neglect in Children Linked to Increased Stroke Risk Later in Life

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