Type 2 Metabolic Surgery is Still Bariatric Surgery

The new bariatric surgery guidelines cite effectiveness, cost efficiency, and safety as reasons to consider the procedure. With all the problems I am finding, I have serious doubts about the long-term safety.

The International Diabetes Federation Taskforce on Epidemiology and Prevention of Diabetes convened a consensus working group of diabetologists, endocrinologists, surgeons and public health experts to review the appropriate role of surgery and other gastrointestinal interventions in the treatment and prevention of type 2 diabetes. The specific goals were: to develop practical recommendations for clinicians on patient selection; to identify barriers to surgical access and suggest interventions for health policy changes that ensure equitable access to surgery when indicated; and to identify priorities for research.

Bariatric surgery can significantly improve glycemic control in severely obese patients with type 2 diabetes. It is an effective, safe (questionable) and cost-effective therapy for these patients. Surgery can be considered an appropriate treatment for people with type 2 diabetes and obesity that have not achieved the recommended treatment targets with medical therapies, especially in the presence of other major comorbidities. The procedures must be performed within accepted guidelines and require appropriate multidisciplinary assessment, comprehensive patient education and ongoing care, as well as safe and standardized surgical procedures.

The last sentence above does describe what must be done and has not been done in the past by a lot of surgeons and primary care physicians or other doctors.

Metabolic, or weight-loss, surgery quickly and dramatically improves blood glucose control. Until now, however, it has not been included in clinical practice guidelines as a treatment option for people with diabetes. The Statement and Clinical Guidelines were published in the June 2016 issue of Diabetes Care, available in print and online on May 24, 2016.

Despite continuing advances in diabetes pharmacotherapy, fewer than half of adults with type 2 diabetes attain therapeutic goals designed to reduce long-term risks of complications, especially for glycemic control, and lifestyle interventions are disappointing in the long term. Metabolic surgery, on the other hand, has been shown to improve glucose homeostasis more effectively than any known pharmaceutical or behavioral approach. Despite such evidence, to date, metabolic surgery had not been included in clinical guidelines for diabetes care as a recommended intervention.

According to the new guidelines, metabolic surgery should be recommended to treat type 2 diabetes in patients with Class III obesity (BMI greater than or equal to 40 kg/m2), as well as in those with Class II obesity (BMI between 35 and 39.9 kg/m2) when hyperglycemia is inadequately controlled by lifestyle and medical therapy. It should also be considered for patients with type 2 diabetes who have a BMI between 30 and 34.9 kg/m2 if hyperglycemia is inadequately controlled. The Consensus Statement also recognizes that BMI thresholds in Asian patients, who develop type 2 at lower BMI than other populations, should be lowered 2.5 kg/m2 for each of these categories.

These conclusions are based on a large body of evidence, including 11 randomized clinical trials showing that in most cases surgery can either reduce blood glucose levels below diabetic thresholds (“diabetes remission”) or maintain adequate glycemic control despite major reduction in medication usage. While relapse of hyperglycemia may occur in up to 50% of patients with initial remission, most patients maintain substantial improvement of A1C long term.

Economic studies also show that metabolic surgery is cost-effective. The authors of the new guidelines recommend that healthcare regulators introduce appropriate reimbursement policies for metabolic surgery for people with type 2 diabetes.

Gastric-Bypass Creates Hypoglycemia Problems

If you are concerned about hypoglycemia, then this article should scare the dickens out of you. The title grabbed my attention - Gastric Bypass Reduces Symptoms, Hormonal Responses to Hypoglycemia. In other words, after gastric bypass surgery, you will have even fewer symptoms and other responses to hypoglycemia, i.e., you will be operating more in the blind and may not have any knowledge you are having hypoglycemia.

Gastric bypass surgery patients have lowered glucose levels and frequent asymptomatic hypoglycemic episodes, Niclas Abrahamsson, MD, PhD, from Uppsala University in Sweden, and colleagues examined symptoms and hormonal and autonomic nerve responses in patients exposed to hypoglycemia before and after gastric bypass. Twelve obese patients without diabetes underwent hyperinsulinemic hypoglycemic clamp before and after gastric bypass surgery.

The researchers found that after surgery the Edinburgh Hypoglycemia symptom delta scores during clamp were attenuated from 10.7 to 5.2. Marked reductions in glucagon, cortisol, catecholamine, and sympathetic nerve responses to hypoglycemia were seen after surgery. A delayed response was seen in growth hormones, but to a higher peak level. During hypoglycemia, glucagon-like peptide-1 and gastric inhibitory peptide increased, but to a lesser extent after surgery.

Catecholamine is any of a group of sympathomimetic amines (including dopamine, epinephrine, and norepinephrine), the aromatic portion of whose molecule is catechol.

Gastric bypass surgery causes a resetting of glucose homeostasis, which reduces symptoms and neurohormonal responses to hypoglycemia, the researchers wrote. Further studies should address the underlying mechanisms as well as their impact on the overall metabolic effects of gastric bypass surgery.

All this leads to problems for people with diabetes that do not recognize when they are having an episode of hypoglycemia and possibly means that they could go into a coma and die. Not a pleasant outlook for these people. Yet this is not something that the bariatric surgeons will pass on the prospective patients.

Life after Bariatric Surgery in Adolescents

The authors of this study say the benefits of weight loss surgery for younger patients may persist for years. Since this was only a three-year study, I think this is a lot of speculation on their part.

While adolescent obesity is becoming an epidemic, with numbers doubling from 800 to 1,600 from 2003 to 2009 or six years, the bariatric surgeons must be licking their chops for the additional income.

Bariatric surgery is one of the feasible therapies for seriously obese adolescents. It includes a variety of procedures: reducing the size of a stomach with a gastric band, or removal of a portion, or resecting or rerouting to a small stomach pouch. To date there have been limited prospective studies analyzing BMI and other outcomes of currently used procedures. The purpose of the study is to examine the efficacy and safety of bariatric surgery in adolescents, even years after treatment.

The study was a multicenter, observational study using adolescents who were less than 19 years of age. They had to be obese and were recruited for undergoing bariatric surgery. The Committee of the study was made up of a Principal Investigator, a Data Coordinator, and a project scientist; this took place from March 2007 to February 2012. Data was collected at 6 months, 1, 2 and 3 years postoperative, with most research visits taking place at clinical centers or the subjects’ homes. Outcomes measured were weight loss, quality of life, coexisting conditions and micronutrient outcomes, using linear mixed and separate models. Poisson regression was also used to calculate unadjusted rates and 95% confidence interval.

Of the 242 adolescents recruited, 161 (67%) did Roux-en-Y gastric bypass and 67 (28%) did sleeve gastrectomy. 98% of participants had a BMI of more than 40, with the majority from a low income household. 99% of the cohort participated and completed 88% of all postoperative visits through the 3-year study endpoint. 90% completed all visits at 1 year, 89% at 2 years and 85% at 3 years. The mean weight reduction at 3 years was 41 kg, with a mean percentage weight loss of 27% (95% confidence interval).

At baseline, all participants were obese with a BMI greater than 30, but by 3 years 26% were no longer obese. 96 participants had an elevated blood pressure at baseline, but normalized by 3 years after their surgery with 74% of them having 95% confidence interval. For 171 participants with dyslipidemia at baseline, 66% were at a normalized value at 3 years (95% confidence interval) without lipid-lowering therapy drugs. For participants with abnormal kidney function, 86% of them had a normalized kidney function (95% confidence interval). For diabetes, there was no improvement in patients with type 1 after 3 years, but type 2 had a confidence interval of 95%, median glycated hemoglobin of 5.3%, a median fasting glucose of 88 mg/dl and median insulin of 12 IU/ml. The mean quality of life score was 63 (95% CI) at baseline, but increased to 83 by 3 years with a P less than 0.001 after the surgery.

For nutritional measures, patients had low levels of ferritin at the end of 3 years from baseline with 57% (95% confidence interval) and P less than 0.001. For vitamin B12, only 8% had a deficiency at the end of 3 years as compared to a baseline of 35%. 16% of participants who went through this surgery had vitamin A deficiency at the end of 3 years. One participant died from complications of hypoglycemia 3 years after surgery. Of the intra-abdominal procedures related to bariatric surgery 24% were performed within the first year, 55% within the second year and 21% within third year.

In conclusion, there was a significant reduction of weight, obesity, and coexisting conditions, and increase in their quality of life. However, there were specific deficiencies in micronutrients; therefore, multivitamin and mineral supplementation is needed. Abdominal procedures show an increased risk with bariatric surgery in the adolescent population.

A study of 53 younger adolescents with a mean age of 14 years had a mean BMI decrease of 20 and an increase of 5 cm in mean height 3 years after sleeve gastrectomy. This indicates that adolescents can lose a clinically significant amount of weight after bariatric surgery, and the majority of patients were able to maintain meaningful weight loss for at least 3 years.

The weakness of this study includes the use of a small population size, especially the diabetes sample size; also, the observational nature of the study introduces heterogeneity into the data. Additionally, the lack of a control group made it difficult to place the postoperative changes in weight and health status completely into perspective since behavioral treatment can result in modest improvement in weight and cardio-metabolic health.

Adverse Topics in Bariatric Surgery

On Saturday, Max called and asked if I could come to his place. I agreed and when I arrived, Tim, and two other members of our support group were present. Max said that the three of them had been approached by the hospital and doctors to have bariatric surgery. Max said he had turned them down, but the other two had agreed to an appointment which would be the following Wednesday to see if they qualified for the surgery.

Max asked me if I had been approached and I said not this time. Max said he would not consider bariatric because of all he had read and that I had blogged about recently. I said there is a lot more that needs to be blogged about and I have five or more topics to work on writing. One of the two spoke up then and asked why we would not consider bariatric surgery.

Max and I started listing the reasons:

• You would not be told everything you will need to know
• You will only be able to eat a spoonful of food at any one time.
• You will need to wait once you swallow before you can have a swallow of water
• You cannot drink or should not drink any alcohol
• You may have diarrhea or vomiting
• You will have many vitamin and mineral deficiencies and may require shots for the vitamin and minerals to be of any value
• Most oral medications may no longer work
• Insulin may be required to manage your diabetes
• You will need mental health counseling
• You will possibly lose the ability to detect hypoglycemia
• About three to five plus years later, your risk of suicide increases

I said these are the ones we can think of immediately, but there are more. Yes, your diabetes may be put in remission about 12 to 18 months after the surgery, which is a good thing.

The next thing you need to be aware of is the small amount of food you will be able to consume without stretching you stomach. This is a big problem for most people and when they do this, they will regain much of the weight and diabetes will return. Several of the people we know have needed a second surgery to repair the stomach and the cycle can repeat itself.

Several things you need to be aware of before consenting to the surgery. Always make sure that you have a meeting about the side effects several days before the surgery is scheduled. Many surgeons rush you into surgery and never cover the side effects. Others present you with a consent form just before surgery and expect you to sign it without reading it. Whenever any of these happen, you would be wise to walk away and never look back.

Many of these surgeons are only interested in the money and not your health. They will not do anything for you after your surgery and seldom cover the things that you need to do following surgery.

A minority of bariatric surgeons will do things correctly and do tests before and after surgery to make sure that your primary care doctor follows through with the care and tests necessary.

Challenges of Preventing Diabetes

Edward C. Chao, DO, is a doctor practicing in the VA San Diego Healthcare System and is an associate clinical professor of medicine at the University of California, San Diego. He is the author of the article I am using for this blog.

Preventing the potentially devastating and often irreversible complications of diabetes, or better yet, keeping the condition itself from even developing, is far less burdensome for patients, costs less to the health care system, and leads to a better quality of life for patients. So, why are increasingly alarming numbers of patients developing prediabetes or diabetes? With all the knowledge we now have, where are we coming up short? Why?

We have all heard about the proverbial frog in boiling water. If you drop it in to a pot, it will take decisive, quick action, as it sees the danger; it will jump back out immediately. But if the water is gradually heating up, the frog does not appreciate the risk as keenly. I think patients and diabetes professionals alike sometimes tend to see diabetes this way. It is human nature.

The latest estimates say that 86 million Americans are considered to meet the criteria for prediabetes. The scary part is 90% do not know it. Without delving into the debate over whether this should be considered an entity, can't we be proactive and stem the tide before someone develops type 2 diabetes and add to the 25% of individuals who revert to normoglycemia?

We have read and heard about studies such as the Diabetes Prevention Program (DPP) and several others that show the superiority of intensive lifestyle intervention over metformin for preventing diabetes. What stops our patients from succeeding like the participants in these trials? Here are 3 possible reasons.

Quote:

1. It is not in our (human) nature. We sometimes do not take the long view or consider the big picture. It is all too easy and necessary to focus on what's at hand: the daily stresses and challenges of work, taking care of our families, paying our bills, and maybe sometimes, taking just a tiny slice of vacation to relax. Who has the energy or the time to try to avoid a disease that may not be diagnosed or, if so, may show up years down the road? “I'll worry about that later. I have too many things on my plate, and I just don't have the time to deal with all of that right now” or “That won't happen to me.”
   
   For those with diabetes, some may approach the future with a similar attitude of avoidance. If a patient does not feel any differently when his or her glucose is 200 mg/dl or 300 mg/dl, why spend all of this time testing or performing any of the other multiple self-management tasks that are so crucial to living well with diabetes?
   
   Additionally, we as a society generally are used to and tend to gravitate toward the quick solution, instant messaging, same-day delivery for packages, seeing 50 “likes” on our Facebook page posts within minutes of updating our status. If we run into trouble, we sometimes think: “There's a pill for that.”

2. These studies looking at prevention took place in a different setting, with intensive lifestyle changes complemented by close monitoring and support. But what about translating this to the real world, to the communities in which patients live? Some components of large clinical studies on preventing diabetes, such as intensive lifestyle intervention implemented in the DPP, can be challenging to apply in communities. In one study, Dr Ackermann and colleagues randomly assigned 509 low-income individuals with prediabetes who were overweight or obese. After attending several lessons of the DPP adapted to the YMCA, the mean weight loss at 12 months was 2.3 kg greater for the intervention group vs the standard care cohort. For the 40% of participants who completed 9 or more sessions, the weight loss was 5.3 kg more than those who received standard care.

3. Health is not just the absence of disease or feeling unwell. We must change our mindset, as individuals and as society as a whole. This speaks to the idea of emphasizing the process rather than the product or end goal. Many of us tend to put our focus on the 25-lb weight loss or reaching a target HbA1c of 7.0%. But what about the steps that we have to take daily to make achieving these targets a reality? I heard an analogy once that asked, “What if I gave you a car that was brand new and in perfect condition? It looks and runs great. If anything happens to it, whether it's a scratch or a crash, that's it; you don't get to trade in for a new one. Knowing this, how would you look at it? How would you treat it?”
   
   We must start viewing our health in the same way. We must expand our mindset not only to stamp out diabetes, but to prevent it from even occurring. We can stem the tide and avoid heading down the road towards 1 in 3 Americans with diabetes by 2050. Individually and collectively, we need to both think and act differently. Unquote:

It is obvious from my blog here that the medical community thinks differently and are worried about over diagnosis and causing anxiety in patients. This was not available to me before my diagnosis of type 2 diabetes, but I sure wish it was. I could have done something possibly to have lessened my fight to manage my diabetes.

What is even scarier is that prediabetes is increasing among healthy weight

American adults. See this short article about the percentages as we age.

Organizations That Mislead People

This is a topic that I have been trying to write about for several months, but I would end up having a rant and not much in the way of facts. I may need to rein myself in even in this post, but I am determined to put this before you and maybe help you decide what is right.

First, the American Diabetes Association does not exist for the benefit of the patient, only for the doctors. Why else would they brag about spending only 72 percent of the funds they received for research? You can bet the remaining 28 percent went for their salaries and/or entertainment.

With all the money coming in from Big Pharma, you can believe they have many conflicts of interest and more money for their pockets.

I do not understand why they set the high numbers for A1c and post meal blood glucose levels. Are they so afraid of hypoglycemia that this drives their actions? A1c levels of 7.0% will bring on diabetes complications quite easily.

Now before I am accused of promoting a one-size-fits-all solution, the following are suggestions for your consideration.

		ADA		Reasonable
Topic		Guideline		Goals
HbA1c		7.00%		Below 6.5%
Fasting		Below 100 mg/dl		70 to 95 mg/dl
Pre-meal		70 to 130 mg/dl		70 to 95 mg/dl
Post-meal		Below 180 mg/dl		120 to 140 mg/dl
Before exercise - Low		Above 100 mg/dl		Above 100 mg/dl
Before exercise - High		Below 250 mg/dl		Below 180 mg/dl
Bedtime		Below 180 mg/dl		Below 140 mg/dl

What your goals are or become will depend on your risk tolerance. Many of the members of our support group have goals near or below the reasonable goals above. Many doctors will only use the ADA guideline goals.

The Academy of Nutrition and Dietetics will not tell you to test and will use the ADA guidelines. Many of the Certified Diabetes Educators (CDEs) will not only use the ADA guidelines, but will mandate these. Others that are registered nurses and CDEs will promote nearer the reasonable goals.

I personally have a distaste for the organizations above because they only set one type of goal and do not want you to change because everyone is afraid of hypoglycemia if a person is using insulin or a few of the oral medications that can cause hypoglycemia.

This says nothing about the diabetes complications, which the ADA goals do nothing to prevent and actually encourage. That is the reason most endocrinologists and doctors consider diabetes to be progressive.

Hope for Dialysis Patients, a Wearable Artificial Kidney

No, you cannot go out and buy one today and it will be several years until this device may be available. This is still exciting news for those with kidney problems and will be news until the device is on the market. The artificial kidney is a promising device that will help many people that are unable to find a donor kidney and rely on dialysis. Researchers report that the experimental wearable artificial kidney shows promise as a substitute for dialysis.

The article states that more than 2 million people worldwide with kidney failure require chronic dialysis. These people must follow strict limitations in what they eat and drink.

The current dialysis machines are stationary and they limit what patients are able to do while having dialysis.

Dr. Jonathan Himmelfarb from the University of Washington in Seattle told Reuters Health that, “As a physician who cares for patients with kidney disease, it is my hope that in the future we have something better to offer than we do today for dialysis therapy.” He would like to see “a treatment that can enhance quality of life, allow for more autonomy and opportunity for full rehabilitation, and possibly to extend life as well, compared to today’s available therapeutic options.” “We owe it to our patients to do everything we can to make this a reality,” Himmelfarb said by email.

Dr. Himmelfarb and his colleagues created a continuously operating wearable artificial kidney that was effective in earlier pilot studies where treatment was limited to 8 hours.

Now they report the results of a 24-hour test of the wearable artificial kidney in 11 patients with end-stage kidney disease who had been on dialysis for an average of 15 months. Five patients completed the planned 24-hour treatment period, during which the device performed as expected.

In this trial, there were challenges. One patient had to stop treatment because of clotting of the blood circuit. In two patients, the machines needed new batteries before the end of the 24 hours. Three patients had to interrupt treatment to have gas bubbles removed from the blood circuit. Because of a variety of device-related technical problems, the trial was stopped early, the authors reported in JCI Insight.

There were no serious complications, and all subjects were able to walk around freely while receiving artificial kidney treatment. The patients reported satisfaction with the few side effects, the convenience and flexibility of treatment, the discomfort associated with treatment, and the freedom allowed by the wearable artificial kidney. The researchers say the technical problems will need to be addressed through device redesign and refinement before further long-term studies can be done.

“We would hope to be able to conduct a follow-up trial beginning sometime in the next several years,” Dr. Himmelfarb said. “It will be a number of years before such a treatment can be proven safe and effective, and be readily available to patients living with kidney disease.”

Dr. Karin Gerritsen and Dr. Jaap Joles from University Medical Center Utrecht in The Netherlands, who recently reviewed the current status of wearable kidney development, told Reuters Health by email, "Wearable and portable artificial kidneys are certainly on the horizon, but it will still take a few years before they become widely available.”

“The device may be a very good alternative for daily (nighttime) hemodialysis while operating in a bedside mode,” they said. “This would already be a great step forward compared to conventional in-(clinic) hemodialysis three times a week.”