Diamel Clinical Studies

Open Clinical Research of Food Supplement DIAMEL®
in the Treatment of the Second Type of Diabetes Mellitus

• MEDICAL TEAM:

The Head of Cathedra of Endocrinology

Dr. V.Pirags
Dr. A.Zvaigzne
Dr. R. Ritenberg
Dr.I.Balcere
Dr. I.Strele.

Endocrinology Department of P. Stradina Clinical Hospital

LATVIA

• PRELIMINARY:

Patients with Diabetes Mellitus suffer metabolism violation caused not only by carbohydrates, but also by proteins and fats. In the case of Diabetes Mellitus, Diabetes dislipydemia is often observed, accompanied by a significant increase in the level of low density lipoproteins, a slight growth of chilomicrons and a reduction in the level of high density lipoproteins in the blood. Dislipydemia is of the fourth or, more rarely, the fifth Fredricson type.

Thus for patients with Diabetes Mellitus a strict diet is necessary to limit the quantity of high absorption carbohydrates and fats in the diet. Such a diet sometimes reduces not only the quantity of carbohydrates and lipids, but also other microelements necessary for the normal occurrence of certain physiological processes. Moreover, sometimes a strict diet is not sufficient for normalising the level of fats in the blood. Taking these facts into consideration, manufacturers have developed new formulae of food supplements. One such food supplement suggested for Diabetes patients is DIAMEL®. During two months we studied its influence on different laboratory parameters and on the quality of life of patients with the second type of Diabetes Mellitus.

• Properties of the Food Supplement DIAMEL®

DIAMEL®is a diet food supplement, consisting of lettuce and blueberry extracts, acetylcysteine, arginine, ascorbic acid, cyanocobalamin, zinc sulphate, folic acid, fumaric acid, glycine, calcium pantothenate, L-carnitine, ornithine, pyridoxal. Antioxidants, amino acids, vitamins and microelements improve glucose metabolism and reduce oxidative stress and resistance to insulin.

• Selection Criteria

The volunteers-participants in this research complied with the following demands:
              
    - Clinical diagnosis:
      Second type of Diabetes Mellitus without featuring acute decompensation.
    - There was no necessity to change the hypoglycomise treatment.

• Schedule of Clinical Study

The patients with Diabetes Mellitus (average age 59.7±9.3, males 53%, females 47%) visited the endocrinologist in the consulting department of the Clinical University Hospital. Before beginning the clinical research, the diagnosis (second type of Diabetes Mellitus) was established, and physicians were convinced that there was no recent Diabetes control deterioration and that it was not necessary to change the hypoglycomise treatment. Patients received information about the schedule of the clinical trial and the food supplement. If the patient agreed to participate in the research, the necessary laboratory tests were performed and a life quality questionnaire made out (Table 1).

• Life Quality Questionnaire

All participants in this research answered a questionnaire before and after the research. The life quality questionnaire was designed on the basis of “The short-form-36 health survey” (Rand Corporation and John E.Ware, 1990) for determinating subject indexes of the patients' health. The questionnaire consists of 11 questions, which patients had to answer with 35 parameters. Replies were evaluated on a scale of 100 points (from 0 to 100), from which eight values of life quality were defined:



- physical burden                                                               (10 parameters)
- physical health violations causing limitation of activity  (4 parameters)
- pain                                                                                   (2 parameters)
- social activity                                                                    (2 parameters)
- vitality, energy                                                                 (4 parameters)
- general mental state of health                                         (5 parameters)
- limitation of activity caused by emotional depression    (3 parameters)
- general state of health                                                     (5 parameters)

The question concerning the state of health during the past year was not used for estimation of the above-mentioned indexes. The average standard for each index of population is deduced from exhaustive research. However, this research was carried out mainly in Western Europe and USA, where the life quality essentially differs from that in Latvia. So we used this standard as additional informational data only. In this study we estimated the results by the comparison of data before and after research.

• Statistical Analysis

Statistical analysis was carried out using the SPSS software (version 9.0).

•RESULTS:

• Objective Parameters

During this research all necessary laboratory tests were performed on 16 patients. One patient interrupted the treatment with DIAMEL® due to side effects, such as itching and urticaria. Her case history included diseases such as intolerance of different drugs and food supplements and bronchial asthma. From three patients we have only the laboratory test, because they did not arrive punctually for the tests. As shown in the evaluation of the laboratory tests of 16 patients after four weeks from the start of the study, there were no essential changes. However, the results obtained after eight weeks from the beginning of research showed the statistically correct reduction of the levels of HbA1c and triglycerides. HbA1c, which characterises the average glycemia during 6-8 weeks, decreased by 16% (r=0.028). Before research, the average level of HbA1c was 8.7±0.5, after (8 weeks later) -7.3±0.3 (standard 4.4 - 6.4%). The level of HbA1c of one patient increased and the level of another patient did not change.

Figure 1:Average levels of HbA1c and triglycerides before and after two months' administration of DIAMEL®.

The reduction in the level of Triglycerides during this research was the following: before 2.0 ± 0.2 , after 8 weeks 1.6 ± 0.2. Thus, during two months the amount of triglycerides decreased by 20% (r< 0.037). Statistically correct alteration of other laboratory parameters was not detected. Average alterations of objective parameters are presented in Table 2.

Table 2.Average alterations of objective parameters during research. Average age of patients is 59.7 ± 9.3, males 53%, females 47%.

•Life Quality Questionnaire Estimation

Based on the life quality questionnaire estimation, the statistically correct improvement of indexes of general mental health, physical burden, vitality, social activity, general state of health were established. General mental health, which included physical distress and state of health, improved from 69.5 to 80.6 points (r=0.043) on a 100-point scale, physical burden from 77.6 to 85.7 (r=0.033). The index reflected the physical health violation caused by the limitation of activity, which also has positive dynamics (from 82.7 to 85.5). However, this improvement is statistically incorrect (Figure 2).

Social activity increased from 78.6 before research to 88.4 after two months. This alteration is statistically correct (r=0.005). Physical and social activity, together with vitality and energy have essential growth, accordingly from 57.3 to 69.8 points (r=0.00016 ). There was no negative dynamic for any patient. Also the correct statistics(figure 3) from 43.0 to 52.2 points indicate an improved state of general health (r=0.0053 ). Positive dynamics occurred for indexes, characterised by emotional distress caused by the limitation of activity and pain, but this is statistically incorrect.

• DISCUSSION

At the present time there is no complete concept of the multi-sided influence of DIAMEL® on metabolism processes. As mentioned above, one of the DIAMEL® ingredients, blueberry extract, may reduce the levels of glucose and HbA1c in the blood. However, it is unlikely that such a significant reduction of the level of HbA1c, detected in our research, is caused by blueberry extract alone. It seems more possible that this positive dynamic is associated with the improvement of the patients' quality of life. As follows from the data obtained, the statistically correct improvment of life quality observed in the indexes, reflected physical and social activity, vitality and energy. During research the patients became more physically active (it was observed that some patients lost weight). It is a well-known fact that the reduction of resistance to insulin improves the utilisation of glucose. Moreover, the influence of the other ingredients in DIAMEL® should be considered. The reduction of the level of triglycerides is probably explained by the same reason as HbA1c dynamics. It is well-known that an ingredient such as folic acid reduces the quantity of cholesterol in the blood. The presence of this acid combined with the growth of physical burden and reduction of resistance to insulin essentially improves lipid metabolism.

The positive dynamic of all indexes has been obtained from the analysis of the quality of life questionnaire. It is necessary to note that these indexes of life quality at the end of research were better than the average ones in the USA population. As mentioned above, taking into consideration the considerable difference in life conditions, mental priorities, and life perception between the population of Latvia and that of the USA, the comparison of these indexes is incorrect. Despite the fact that physical and social activity, vitality and other indexes of patients are better, their general state of health is inadequate and was lower both before and after research in comparison with the average ones of the USA population. The positive dynamic was obtained as a result of the above-mentioned research. Despite this, it is viable to continue this work.

• CONCLUSIONS

1.The administration of the food supplement DIAMEL® during two months currently reduces the average glycemia statistics (level of HbA1c reduced by 16%, r< 0.05).

2. The administration of the food supplement DIAMEL® during two months currently reduces triglycerides statistics by 20% (r<0.05), which indicates the reduction of a resistance to insulin.

Clinical Study Regarding the Utilization of the Preparation DIAMEL® in the Treatment of Diabetes Mellitus • MEDICAL TEAM: Chief investigator: Prof. Dr. Dan Cheta Investigator: Dr. Emil Trifan Coordinator from Catalysis: Dr. Horatiu Albu The Institute of Diabetes, Nutrition and Metabolic Diseases "N.C. PAULESCU" Bucharest / ROMANIA July 2002 •PRELIMINARY: • Treated patients: 52 with diabetes mellitus type I and type II (37 men and 15 women). • Treatment:DIAMEL® Capsules for 10 - 12 weeks associated with INSULIN or ADO or as a pharmacological monotherapy. • CONCLUSIONS: The administration of DIAMEL® as a pharmacological monotherapy or as a treatment associated with antidiabetic therapy presents the following advantages: • Improvement of the general condition of 95 % of the patients. • Improvement of physical condition, with an increase of muscular mobility and an improvement of neuropathic signs, especially the peripheral ones. • Decrease of psychical discomfort and depressions, since DIAMEL® has real antidepressive effects. • Improvement as well of male sexual behaviour after the second month of treatment, even in the cases of patients with severe associated affections. • Increase of appetite and weight in general. • Improvement of peripheral neuropathic type symptoms. • Improvement of the general condition of the patients with chronic hepatitis. • Improvement of lipid concentration in blood, reducing insulin resistance. • Significant improvement of hyperuricaemia in all patients with a high level of uric acid in blood. • Increase of the values of calcium and magnesium, associated with the disappearance of tetany syndrome in the majority of the patients. • During the study, patients' compliance improves considerably because of DIAMEL® being a natural product, thus improving their implication in antidiabetic treatment. • T.G.O., T.G.P. and G.T.P. values of the patients who presented alterations were normalizing after treatment with DIAMEL® and HbA1c value in general moved towards the normal zone. • DIAMEL® can be used as a hypo-glycaemic preparation for diabetes mellitus type II, obese or non-obese people, associated with a strict diet. • DIAMEL® stimulates, in a positive sense, hepatic mechanism, reducing metabolic liver affections. • DIAMEL® does not generate dependency, is well tolerated and does not have any side effects. • Half of the patients treated with DIAMEL® presented a clear improvement of life quality.

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Open Prospective Clinical Study on Treatment in 40 Diabetes Mellitus Type I and II patients (DMID, DMNID) with DIAMEL® (Complementary Foodstuff Based on Lettuce and Oligoelements) • MEDICAL TEAM: Dr. Maria Ester L. Franco- Diabetology Dr. Elida Rosa Martinez- General Medicine Dr. Infieri Jacinta Arana-M. Clínica Médica Especializada, La Casa del Diabético Tegucigalpa M.D.C. / HONDURAS year 2000 • PRELIMINARY: • Treated patients: 36 with diabetes mellitus type I and type II (37 men and 15 women). • Treatment: DIAMEL® Capsules for 10 - 12 weeks associated with INSULIN or ADO or as a pharmacological monotherapy. • CONCLUSIONS: 1. The product DIAMEL® (complementary foodstuff based on lettuce and oligoelements) has demonstrated itself to be a product that complies with expectations and which naturally stimulates the organism, which factors we consider desirable for the diabetic patient. Its most important aspect is that it is a product with natural ingredients made of: amino acids, antioxidating vitamins and oligoelements which act as bio-catalyzers. In this manner, it stimulates the good functioning of the organism and the cells of the pancreas. 2. The product DIAMEL® has demonstrated in a short time (2 months) that it is capable of reversing the physiopathology of diabetes, since 4 of our patients no longer use insulin. 3. To confirm the absolute effectiveness of the product and the hope of cure over the medium or long term, it is hoped to be able to measure the insulin levels over a period of 6 months and one year, to confirm the degree of stimulation of the pancreas upon its exposure to the product DIAMEL®. 4. Of the 4 patients with dx: of feet affected by diabetes, 2 were already in the cicatrization period, but 2 of them had diabetic foot G II and G III respectively, with a great possibility of amputation. Debriding, antibiotics, daily treatment and DIAMEL® were administered, with the 2 patients healing completely. 5. All the patients reported improvement of their symptomatology after 2 months of treatment, which for us demonstrates the excellence of the natural product DIAMEL®.