Part 3 – A deep dive into the treatment options for type 2 diabetes: Intensive lifestyle change

This post looks at a third treatment option for patients living with type 2 diabetes: intensive lifestyle change to achieve remission. Our two previous posts in this series covered medication management, which focuses on diabetes control, and gastric surgery, which focuses on remission – defined as achieving normal blood glucose without diabetes pills or injections.

There are three kinds of programs to help people achieve remission of type 2 diabetes through intensive lifestyle change. They focus on: 1) low calorie consumption; 2) very low carbohydrate consumption; and 3) lifestyle medicine, stressing a whole food, plant-based (WFPB) eating style and low calorie intake. Here, we outline these three different approaches in terms of the patient experience, program challenges, and program sustainability.

What are the research foundations of these approaches?

Our knowledge today about remission for type 2 diabetes builds on large observational studies and clinical trials that advanced our basic understanding of the significant patient behavior change needed to achieve consistent weight loss and improved metabolic control.

The three notable studies that follow provided some of this foundational work.

The National Weight Control Registry (NWCR) tracked3,591 people (some of whom had type 2 diabetes) who had initially lost at least 30lbs and kept the weight off for a year or more. Its members lost an average of 66 lbs., lost this weight either slowly or quickly, and kept it off for 5.5 years. Type 2 remission was not the focus, but behavior insights were gained: forty-five percent lost the weight on their own and 55% with the help of a structured program. To succeed, most used a low-calorie, low-fat diet; 78% ate breakfast every day; 75% weighed themselves at least once a week; 62% watched fewer than 10 hours of TV per week; and 90% exercised about 1 hour per day.

The Action for Health in Diabetes’ Look AHEAD study was a clinical trial involving approximately 5,000 overweight people with type 2 diabetes. The study tested whether a weight-loss program with modest calorie reduction (down to 1,200-1,800 calories a day); a diet with a low percentage of fat (30%) and comprised of liquid shakes or meal bars; and clinical support from a diabetes educator, was better than support from a diabetes educator alone. A modest goal of 7% weight loss was set for patients, along with a goal to engage in at least 175 minutes of physical activity per week. Results showed that diabetes remission was achieved by 9.2% of the intervention patients at 2 years and 3.5% of patients at 4 years, compared with 1.7% of patients and 0.5% of patients, respectively, in the group that only received support from a diabetes educator.

A Kaiser Permanente study of122,781 adults with type 2 diabetes tracked participants over 7 years. The study showed that in the general population, 1.6% of patients go into remission with usual primary care, and 4.6% were in remission within 2 years of diagnosis. So, while uncommon, remission does happen with type 2 diabetes in general practice, and it is not always a “progressive disease”.

These studies help us understand that remission in type 2 diabetes is possible. They also illuminated essential program techniques: measuring behaviors; goal setting; problem solving; understanding patient interests and barriers (and helping solve them); controlling cues to eating; and providing continuous patient encouragement and support. Today’s remission-focused, weight-loss programs for people with type 2 diabetes have taken these insights to the next level, offering more intensive approaches that differ in their clinical assumptions, patient experience, and success.

Here are some high-profile examples of programs on the market today:

1. Low-calorie programs for remission

Diabetes Remission Clinical Trial, DiRECT

The DiRECT clinical trial centers around a low-calorie, intensive program for type 2 remission. It targets short-duration type 2 diabetes (<6 years) in a UK primary care setting. In the initial 12-20-week weight-loss phase, where the target is for patients to achieve a 15kg (approximately 33 lbs) drop in body weight, the focus is exclusively on changes to food – there is no exercise component in this phase. This is followed by a phase of support to reintroduce real food gradually, with an increase in physical activity (steps), and then a final phase focuses on providing support for weight maintenance. The clinical approach is based on the “twin cycle hypothesis”, which states that type 2 diabetes occurs due to excess calorie intake over many years, leading to weight gain and the accumulation of liver fat. Liver fat induces hepatic insulin resistance, which results in compensatory, high-circulating insulin levels in the blood, leading in turn to a self-reinforcing cycle by which insulin stimulates fat production in the liver. These excess fat deposits overflow into the system and are deposited elsewhere, including the pancreas of genetically susceptible individuals. This leads to type 2 diabetes by eventually reducing the organ’s ability to maintain adequate insulin production to meet the high demands of insulin resistance and excess food energy. Individuals differ in their capacity to store fat in safe deposits under the skin, and when their personal fat threshold is exceeded – which for some is at a very high weight and for others when they are only slightly overweight – they accumulate metabolically harmful ectopic fat in the wrong places. This fat is easily mobilized, but this requires significant weight loss of around 15% of initial body weight, which is most rapidly achieved with this type of rigorous dietary approach.  

The program’s intensive, initial lifestyle phase involves meal-replacement shakes and soups and consumption of 825–853 kcal per day for 3-5 months, comprised of 61% calories from carbohydrate, 26% from protein, and 13% from fat. This is followed by a gradual reintroduction of food, using the plate method, in which half of plate is filled with non-starchy vegetables, a quarter with starchy vegetables, and a quarter with protein options. Behavior maintenance support is provided for 2 years. The DiRECT program looks at the quantity, not quality of food as the main issue with type 2 diabetes. Also, the researchers expect that patients will need to cut back calories by 30% from their baseline levels in order to maintain weight loss and diabetes remission status.

The DiRECT study results showed that at 12 and 24 months, 46% and 36% of patients, respectively, achieved type 2 diabetes remission with no diabetes medications used. Remission was related to how much weight was lost: if more than 15kg (approximately 33lbs) were lost, the remission rates were 86% and 83% at 12 and 24 months, respectively.

The DiRECT group has also shown, through basic, clinical research, how fat accumulation in the liver and pancreas drops dramatically as a result of this program (see figure below).

A related study investigated the physiological mechanism of ‘relapse’ among a subgroup of DiRECT study participants, quantifying liver and pancreas fat and looking in detail at liver-fat export at 12 and 24 months. Those who initially attained remission but reverted to diabetes during the study period, re-accumulated liver and pancreas fat, lending further support to the twin-cycle hypothesis.  

DIADEM Study

Based on the protocol for the DiRECT study,the DIADEM study used another very-low-calorie, intensive, type 2 remission program. It involved a younger group of patients living in Qatar, who had shorter duration type 2 diabetes (<3 years). In addition to the diet restrictions, the program had an additional physical activity component. It was adapted to the local cultural needs of patients from the Middle East. The results showed that type 2 diabetes remission occurred for 61% of patients in the intervention group, compared to 12% of those in usual care. This remission rate was higher than the 46% achieved in the DiRECT program but was consistent with the fact that there were younger patients involved, and they had a shorter diabetes duration and a lower starting blood glucose level.

2. Very low carbohydrate program for remission

Keto

Ketosis occurs when the body switches from carbohydrates for cellular fuel to ketones, coming from either dietary or stored fat. Ketosis is an evolutionary survival mechanism for humans during starvation periods. There are several online programs that use ketosis to achieve type 2 diabetes remission through a keto diet. In these programs, there are no calorie limitations, but the dietary restrictions include that only 30 grams of daily carbohydrate are permitted; 75% of calories should come from fat; and no more than 20% of calories should come from protein. Remote patient coaching and monitoring, often via a patient app, are provided along with medical supervision and peer support. Recipes are provided for meals very high in fat. In one such commercial, digitally-supported program, results showed that 60% of patients were in remission at 12 months and 53.5% at 24 months. Of those counted as in remission, 26.8% were still using metformin as an oral agent medication. Some of the medical concerns that surround the keto diet are its effective exclusion of plants as a food source and the subsequent loss of anti-oxidants, phytonutrients, and plant fiber in the diet. What people who question the diet say is that dietary patterns, such as keto, that do not resemble the historical food patterns of humans globally (largely WFPB, carbohydrate based) may not be sustainable as a scalable, life-long intervention for people living with type 2 diabetes.

3. Lifestyle medicine for remission

The American College of Lifestyle Medicine and the lifestyle medicine subspecialty

Lifestyle medicine stresses a whole food, plant-based (WFPB) eating style that replaces highly processed foods and sugar-sweetened drinks (the current cultural norm) with mostly whole grains; fruits and vegetables; and nuts, seeds, and legumes, as part of a holistic patient approach. Lifestyle medicine stresses the importance of good sleep, regular physical activity, strong social bonds, reduction of chronic stress, freedom from addictive drugs, and finding a healthy balance in life between work and play. While low-calorie programs that use liquid replacement meals and keto programs that remove carbohydrates indirectly remove highly processed foods and sugar-sweetened drinks as a result of their dietary restrictions, WFPB purposefully replaces these with a largely whole food, plant-based eating pattern. Lifestyle medicine stresses “appropriate dosing” of the WFPB eating pattern to involve a low-energy intake of these calories, between 600-1100 per day to create remission. The research and evidence base for type 2 diabetes remission using lifestyle medicine is currently limited to: 1) case studies and clinical practice reports; 2) clinical trial evidence from studies of the Mediterranean diet on metabolic syndrome; and 3) reports on the global “Blue Zones”, which are five regions of the globe with low rates of type 2 diabetes (even among their elderly), and the reports are based on non-scientific observations of local lifestyles, social habits, and demographics.

What would a type 2 diabetes remission program for the 21^st century look like?

Research to date provides evidence that meaningful type 2 diabetes remission is possible with early intervention, aggressive lifestyle change, lifelong behavior change support, significant weight loss (10-15% of body weight), and a shift in diet quality from modern, highly processed foods and drinks, to a whole food, plant-based pattern. Remission strategies are effectively a response to major cultural change in the US and globally over the past 50 years. The next step is to strengthen our current remission approach to fit the needs of the 21^st century through innovative, scalable strategies.

1. Today, we are surrounded by unhealthy, highly processed foods and sugar-sweetened drinks. We must help patients and clinicians become more aware of the dramatic environmental and lifestyle changes over the past 50 years in our national food supply and eating habits.
2. Given that remission results to date are short term (1-2 years), we must plan to build financially sustainable programs that acknowledge type 2 diabetes as a lifelong journey.
3. We should direct or recommend that research and commercial programs collect data on the total costs of medical care to build the business case for long-term, type 2 remission programs.
4. Program evaluations should track the psychosocial benefits to the patient from living in remission, enabling the measurement of changes in treatment burden, emotional distress, depression, and quality of life.
5. We must provide patients with the information, motivation, and behavior skills they need to succeed and thrive on this lifelong journey.
6. We should pivot quickly from our current research studies, which are based on small, highly selected patient groups, and create highly scalable and even more ambitious patient programs that:
   • Feature a blended, in-person/virtual support team (MDs, nurses, health coaches, peers, dietitians) and remote patient monitoring to reflect the realities of the post-COVID-19 world.
   • Avoid extreme limitations on food options (e.g. “omit all animal products”) or narrow cultural approaches that may dissuade patients or families from joining programs.
7. We should expand and integrate meal delivery services that offer whole food, plant-based options to replace liquid meals for the intensive, structured eating phase, as well as “MD prescription” strategies to engage patients.
8. Let’s build partnerships that increasingly leverage lifestyle medicine as a central organizing medical specialty and create an expanded network for global, type 2 diabetes remission programs.

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