ADA Consensus Statement Admits Recommended Lifestyle Intervention Fails; Solution: Medication

In the August issue of Diabetes Care a new consensus statement was published, Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association [ADA] and the European Association for the Study of Diabetes [EASD]

The statement is said to be based on evidence from well-controlled trials and the expert opinions of diabetes specialists. At its heart, the document stresses the importance of prompt diagnosis of type 2 diabetes and achivement of HbA1c level as close to the nondiabetic range as possible [less than 6%] or, at a minimum, to 7% or less.

"Our consensus is that an A1C of 7% should serve as a call to action to initiate or change therapy with the goal of achieving an A1C level as close to the nondiabetic range as possible or, at a minimum, decreasing the A1C to less than 7%. We are mindful that this goal is not appropriate or practical for some patients, and clinical judgment, based on the potential benefits and risks of a more intensified regimen, needs to be applied for every patient. Factors such as life expectancy and risk for hypoglycemia need to be considered for every patient before intensifying therapeutic regimens."

Later in the statement, it's abundantly clear that diabetes researchers and experts know that the dietary intervention recommended does not work for the long-term. Rather than question the dietary recommendations, or explore emerging data supportive of dietary interventions that are different from the recommendations, the statement instead concludes that "the limited long-term success of lifestyle programs to maintain glycemic goals in patients with type 2 diabetes suggests that a large majority of patients will require the addition of medications over the course of their diabetes."

The final sentence in the section discussing medications, which followed the section on lifestyle intervention, sets the stage for what is to come, "addition of medications is the rule, not the exception, if treatment goals are to be met over time."

The section discussing How to Initiate Diabetes Therapy and Advance Intervention is eye-opening:

The patient is the key player in the diabetes care team and should be trained and empowered to prevent and treat hypoglycemia, as well as to adjust medications with the guidance of health care providers to achieve glycemic goals. Many patients may be managed effectively with monotherapy; however, the progressive nature of the disease will require the use of combination therapy in many, if not most, patients over time to achieve and maintain glycemia in the target range.

And, with the stage set, we find the algorithm is predictable: diet & medication, then add insulin.

Oh, you thought it would be lifestyle intervention to see how effective that is?

Well, not exactly.

Step 1: lifestyle intervention and metformin

[O]ur consensus is that metformin therapy should be initiated concurrent with lifestyle intervention at diagnosis. Metformin is recommended as the initial pharmacologic therapy, in the absence of specific contraindications, for its effect on glycemia, absence of weight gain or hypoglycemia, generally low level of side effects, high level of acceptance, and relatively low cost. Metformin treatment should be titrated to its maximally effective dose over 1–2 months, as tolerated. Rapid addition of other glucose-lowering medications should be considered in the setting of persistent symptomatic hyperglycemia.

Step 2: additional medications

If lifestyle intervention and maximal tolerated dose of metformin fail to achieve or sustain glycemic goals, another medication should be added within 2–3 months of the initiation of therapy or at any time when A1C goal is not achieved. There was no strong consensus regarding the second medication added after metformin other than to choose among insulin, a sulfonylurea, or a TZD. As discussed above, the A1C level will determine in part which agent is selected next, with consideration given to the more effective glycemia-lowering agent, insulin, for patients with A1C greater than 8.5% or with symptoms secondary to hyperglycemia. Insulin can be initiated with a basal (intermediate- or long-acting) insulin.

Step 3: further adjustments

If lifestyle, metformin, and a second medication do not result in goal glycemia, the next step should be to start, or intensify, insulin therapy.

The authors concede in the conclusion, "We now understand that much of the morbidity associated with long-term complications can be substantially reduced with interventions that achieve glucose levels close to the nondiabetic range. Although new classes of medications, and numerous combinations, have been demonstrated to lower glycemia, current-day management has failed to achieve and maintain the glycemic levels most likely to provide optimal health care status for people with diabetes."

I don't know about you, but the admission that the dietary & lifestyle intervention promoted by the ADA doesn't work should be a wake-up call to evaluate the data on various dietary interventions, rather than be used as a reason to throw our hands up and think throwing pharmaceuticals at the problem is all we can do to solve the problem.

The "problem," quite frankly, is the diet recommended - it is the exact opposite of a dietary approach necessary to reduce blood sugars effectively over the long-term. It sets the stage for continued, progressive deterioration because it does not address the underlying cause of the metabolic distrubances that, in time, lead to type II diabetes.

Until the underlying cause of the progressive deterioration experienced by those with type II diabetes is addressed, no amount of medication is going to stop the continued progression of the disorder. Those with type II diabetes, in the long-term, even with this new algorithm, can only look forward to a continued, progressively worse HbA1C, blood sugar, cholesterol, blood pressure, adiposity, and the resultant complications to their eyes, nerves, kidneys and cardiovascular system.

Because, until the insulin resistance, fueled by hyperinsulinemia, is addressed, no amount of pharmaceutical intervention is going to reverse or stop the damage occuring from within. Granted, it will probably slow it down, but it's not going to stop the damage that continues within the body while in a state of metabolic chaos. The only way to do that is to return the metabolism to a state of balance.

In a hyperinsulin state, balance can only be achieved when demand for insulin is reduced; and reduced demand for insulin can only happen when blood sugars are lowered and stabilized over a period of time.

As the statement makes clear, we can do that with drugs. We can force the pancreas to secrete more insulin to lower blood sugars; we can decrease hepatic glucose output and lower fasting glycemia; we can reduce the rate of digestion of polysaccharides in the proximal small intestine, primarily lowering postprandial glucose levels; we can increase the sensitivity of muscle, fat, and liver to endogenous and exogenous insulin; and when all that fails, we can add insulin, which can "decrease any level of elevated A1C to, or close to, the therapeutic goal."

Or we can address the underlying hyperinsulinemia and reach targets with lifestyle intervention alone. The experts who penned this consensus statement believe it cannot be done with a lifestyle intervention alone.

Remember, early in the statement, "our consensus is that metformin therapy should be initiated concurrent with lifestyle intervention at diagnosis."

That's because, to be repetitive here, the ADA dietary recommendations for those with type II diabetes is worthless as a first line defense for anyone diagnoised with type II diabetes. They know it.

They also know there are hundreds of studies published and readily available that show strong support for a dietary intervention they will not consider - a low-carb diet.

In every study available, where subjects complied with a truly low-carb diet, the results cannot be ignored...statistically significant improvements in every risk marker for type II diabetes:

• HbA1C
• Fasting Blood Sugars
• Glucose Tolerance
• Insulin
• Uric Acid
• Total Cholesterol
• HDL
• TC:HDL Ratio
• Triglycerides
• Insulin Sensitivity
• Weight Loss
• Waist-hip Ratio
• Blood Pressure
• BMI
• Renal Function

Also, add to this impressive list - reduction or elimination of medications for diabetes, dyslipidemia, and/or hypertension.

Instead of considering this alternative, the ADA and the EASD consensus is to continue recommending a dietary approach understood as worthless and now add pharmaceutical intervention at diagnoisis since they know the diet alone isn't going to do squat for the long-term.

If you were paying attention earlier, this new line of treatment comes complete with recommendations to achieve compliance in patients, who will be "trained," and whose treatment will be "managed" and "implemented by health care professionals with appropriate training, usually registered dietitians with training in behavioral modification."

All because "[t]he authors recognize that for most individuals with type 2 diabetes, lifestyle interventions fail to achieve or maintain metabolic goals."

Sadly, the only dietary approach considered as part of the failed "lifestyle intervention" is the one promoted by the ADA - a diet rich with carbohydrate that only makes things worse for those with type II diabetes.

And, [yes, I'm repeating myself again] instead of challenging the notion that diabetics "need" carbohydrate, and lots of carbohydrate, we're talking 55% of energy each day - the "experts" continue down the road to the inevitable, next logical step when they won't acknowledge the underlying problems caused by the dietary recommendations, and come to the only thing left - let's add drugs earlier in the management of type II diabetes.

Based on the evidence they chose to review and cite in the paper, their recommendations and conclusions are understandable. The biggest problem though, is they failed to consider or acknowledge any evidence or data outside the accepted dogma that those with type II diabtes need a diet where the majority of calories each day come from carbohydrate.

Don't even think to tell me there isn't any data supporting carbohydrate restriction; or try to concede it's there but too short term to even consider; or that diets that reduce carbohydrate lead to other complications - not a valid arguement when the statistically significant improvements thus far are found in the very risk markers that improvement is called "reduction of risk" of these so-called problems that "may" happen in the long-term for those with type II diabtes.

The laundry list of long-term "potential" complications, that "may" happen if one follows a low-carb diet over the long-term can be summed up as the very same list - cardiovascular disease, high blood pressure, dyslipidemia, osteoporosis, kidney failure, etc. - that those already diagnoised with type II diabetes and currently following the recommendations are doomed to given the progressive deterioritation that can be predicted, with certainty, following the current recommendations.

This new algorithm is placing a band-aid on the symptom - we know a band-aid doesn't make a cut magically disappear or go away - it covers the cut, you can no longer see the cut, but the cut is still there!

The progressive deterioritation will remain a certainty unless the underlying cause of the metabolic chaos is addressed - medicating the problem is not resolving the problem.

It is not restoring balance in the metabolism. So, while this new consensus statement is going to become gospel in the world of diabetes educators and healthcare providers, it's not doing anything to stop or reverse the train-wreck happening in the metabolism.

With an estimated one-third of the adult population in the United States already diagnoised with diabetes or pre-diabetes, isn't it time we take this seriously enough to adopt an evidence-based approach that is truly based on evidence?

As it stands, we're in the middle of an impending crisis in our health and healthcare system. The band-aid, that is throwing more drugs at the problem, is not going to solve this crisis and is not our only option.

I've said it before, and I'll say it again - Diabetics Must Demand Accountability from the ADA!