In contrast to the standard dietary approach, diet plans which include meal replacements have been proved as an appropriate tool for weight reduction and for long-term weight loss maintenance in obese subjects and also in obese patients with T2D. As individuals with diabetes appear to be less successful in weight loss and weight loss maintenance than nondiabetic individuals, the meal replacement strategy is particularly challenging in individuals with diabetes. The weight loss results of studies with meal replacements have made feasible a large long-term study: Action for Health in Diabetes. This study with approximately 5,000 overweight volunteers with T2D sponsored by the NIDDK and the NIH (www.niddk.nih.gov/patient/SHOW/lookahead.htm) will evaluate the long-term health effects of an intensive lifestyle intervention designed to achieve and maintain weight loss. This program is compared to a control condition involving a program of diabetes support and education. To help participants achieve and maintain weight loss, diet strategies in the form of meal replacements (e.g. prepared meals and liquid formula), exercise strategies and optional weight loss medications are utilized. The primary outcome is the occurrence of cardiovascular events including myocardial infarctions and strokes and cardiovascular deaths.
The study will be conducted over a 13-year period, and the results are not available before the year 2012.
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Dr. Hill: I really want to congratulate you for doing the long-term studies, because in the area of obesity treatment short-term studies tell us very little. Do you think of meal replacements as a drug so that their use will continue forever? If people don't continue to use them, won't they regain weight? So even though you have done a long-term study, the question is what happens over the even longer term? Will people have to return to real foods eventually and what will happen to their weight when they do?
Dr. Ditschuneit: That is a very important issue in the treatment of obesity with meal replacements. Meal replacements are considered to be drugs, at least by some patients. The question when to return to conventional food is nearly always present. Many patients are doing well with the meal replacement plan and follow it to achieve the body weight that they strive for. After that, more and more they return to conventional meals. In the case of weight regain, they can again use meal replacements. Corresponding to the weight changes there will be a balance between meal replacements and real food.
Dr. Katsilambros: I would like also to congratulate you for the long-term study. How much protein and how much carbohydrate are there in the meal replacements?
Dr. Ditschuneit: In the 4-year study, each formula in the meal replacement plan contained 17 g protein and 34 g carbohydrates.
Dr Katsilambros: The reason I am asking that is that if you combine carbohydrate and protein you have a very high insulin secretion. If you give preventively more proteins then the insulin secretion is less and perhaps the hunger is less.
Dr. Ditschuneit: In the weight loss phase with two meal replacements and one conventional meal per day and also in the weight maintenance phase with one meal replacement and two conventional meals, 45-50% of energy was derived from carbohydrates, 20-25% from protein and 30% from fat.
Dr. Katsilambros: What kind of carbohydrates?
Dr. Ditschuneit: In the study most of the carbohydrate in the meal replacements was sugar. The remaining conventional meals contained mainly complex carbohydrates. We preferred putting glucose into the meal replacement because we had the impression that the patients felt better. We think that somehow the sympathetic nervous system was activated through stimulation of insulin secretion after uptake of glucose and amino acids.
Dr. Katsilambros: A stimulation but not high, if they are not combined with carbohydrates.
Dr. Ditschuneit: Intensive and detailed interviews with the patients were performed, and the carbohydrate and protein intake was modified if needed.
Dr. Katsilambros: How good was the compliance in the conventional group? What was the reason why they did not loose much weight?
Dr Ditschuneit: Compliance was very good in both groups of patients. Because all the patients had been transferred by a general physician to the university hospital, motivation to follow the study protocol was high. In addition the meal replacements were free for the patients. Compliance in the conventional group was similar to that in the meal replacement group. One reason was that the patients in the conventional group were also promised the meal replacements for free after 3 months. We assume that the weight loss in the patients of the conventional group was lower because they were more tempted by dietary mistakes and due to the lower adherence to the dietary prescriptions. For the patients it has been shown that it is easier to take a portion of controlled meal replacement than to prepare a meal from self-selected conventional foods.
Dr. Katsilambros: But how was the compliance in the conventional group?
Dr. Ditschuneit: Compliance was the same as in the meal replacement group. For the reasons mentioned earlier, compliance within the first 3 months was complete with regard to visits to the hospital.
Dr. Katsilambros: It is very impressive then why they did not lose weight. I remember long ago at the University of Ulm you used the zero diet. What happened to these people? Did you have a follow-up? I am very curious to know.
Dr. Ditschuneit: Between 1970 and 1980 we had experience with starvation in obese patients. This situation was always transient and described as the zero diet. The zero diet was an opportunity for morbidly obese patients to lose considerable amounts of weight within a short time. We have no long-term follow-up of these patients.
Dr. Foreyt: I agree with Dr. Hill, these data just didn't exist before your studies on obesity, so congratulations. I have some questions regarding the maintenance phase. How much lifestyle intervention was necessary? How much counseling did they get when they came in every month or every 2 months? Did you just pass out the meal replacements or did you actually do group therapy or individual treatment for an hour, what happened? Did you measure how much meal replacement they actually took? Was it the counseling or was it the meal replacements or both?
Dr. Ditschuneit: In the maintenance phase patients came in every month, and later at least every 2 months. Group sessions were done regularly. In addition individual consultations and training were done every month by a nutritionist. The time needed for a visit was variable and depended on individual problems. At each visit the number of meal replacements that the patient had used were counted and registered. The long-term outcome of the study was the result of regular and individual counseling as well as the simplicity of the meal replacement program.
Dr. T. Wilkin: Did you suggest that the analysis was on the basis of cases available or intention to treat?
Dr. Ditschuneit: The data were analyzed on the basis of all available cases, intention-to-treat. and of the last values traced back to baseline.
Dr. T. Wilkin: What percentage of those on the meal replacements did you lose at 4 years?
Dr. Ditschuneit: At 4 years, of the 100 patients we lost a total of 25: 14 in the meal replacement group and 11 in the conventional group.
Dr. Gerasimidi-Vazeou: In your study what was the volume of a meal that you gave to replace first the breakfast and second the lunch?
Dr. Ditschuneit: The volume of the meal replacement was 250 ml for breakfast as well as lunch.
Dr. Golay: My concern is for clinicians. Most of the time the patients cannot take liquid diets forever and they eat them on top of the regular diet so they gain weight. In terms of patient education, it is also not a really good idea to propose liquid diets forever. It is better to teach them to eat a regular diet. It is a big problem for me to propose a liquid diet to our patients.
Dr. Ditschuneit: I agree that patients cannot take liquid diets forever and we do not propose this. With a partial meal replacement plan, patients have a structured meal plan and can be taught a healthy diet.
Dr. Golay: I am very pleased to hear that. For a mother with children it is difficult to eat a liquid diet all the time. My best patients for a liquid diet are surgeons; they like this kind of meal because it is fast.
Dr. Ditschuneit: We do not recommend partial meal replacement for children.
Dr. Bantle: I have two comments. First for Dr. Golay, I have no concern about using these products. We use them both in research and in clinical practice and they actually provide better nutrition than meals for many people because they are fortified with vitamins and minerals. You can demonstrate that calcium intake is increased by using meal replacements. The second comment pertains to weight loss in people with type-2 diabetes. I agree that it is more difficult to accomplish than it is in non-diabetic populations. But I don't think that is because they comply with treatment less well. I think the more likely explanation is that the treatment reduces urine glucose so, as they lose weight and plasma glucose declines, the calories previously lost in the urine are retained. Said in a different way, they are actually too thin for their caloric intake because of glucosuria.
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