Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient.
Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient.
Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia due to
 deficiency in either insulin secretion, insulin action, or both. There are different types of
 diabetes. The most common nowadays is type 2 diabetes, characterized by insulin resistance
 and a relative deficiency of insulin secretion, either of which may dominate to a varying
 degree. This form of diabetes occurs mainly in mature adults but can also occur at a younger
 age, or even during adolescence.

 According to estimates, the number of diabetic subjects in the world increased from 153
 million in 1980 to 347 million in 2008. In France, the prevalence of diabetes treated
 increased from 2.6% to 4.4% between 2000 and 2009, reaching nearly 3 million people. Type 2
 diabetes accounts for 92% of cases of diabetes treated, and its share continues to increase
 due to a relative stability of type 1 diabetes and a steady increase in type 2 diabetes (5.4%
 per year). The aging of the population, the increase in obesity and the lack of physical
 activity contribute to the development of type 2 diabetes. According to the Entred study
 conducted in France between 2001 and 2007, four out of five type 2 diabetic patients were
 either overweight (39%) or obese (41%).

 In the long term, unbalanced diabetes exposes to macro-vascular complications such as
 myocardial infarction and stroke, and microvascular complications affecting the peripheral
 nervous system, kidneys, retina may result in amputation of the lower limb, renal failure and
 blindness, respectively. As a result, the risk of death for diabetics is at least twice as
 high as for non-diabetics.

 However, a good control of the disease by a lifestyle adaptation (lifestyle and dietary
 measures, physical activity) with good medical care, and possibly pharmacological, can avoid
 or significantly reduce the risk of complications. The purpose of dietary and lifestyle
 measures is to reduce hyperglycaemia and to control the weight of the patient. The
 implementation of effective dietary measures is a necessary prerequisite for the medication
 treatment of glycemic control and their application should be continued throughout the course
 of treatment. The treatment of other cardiovascular risk factors and complications of
 diabetes is also essential for the management of the diabetic patient.

 The HAS (Haute Autorité de Santé : High Authority of Health) in its latest recommendations
 for a drug strategy for glycemic control of type 2 diabetes emphasizes that the short-term
 goal of decreasing hyperglycemia is the improvement of symptoms (thirst, polyuria, asthenia,
 weight loss and fuzziness visual) and the prevention of acute complications (infectious and
 hyperosmolar coma). The longer-term goal is the prevention of chronic microvascular
 complications (retinopathy, nephropathy and neuropathy), macrovascular (myocardial
 infarction, stroke, and peripheral arterial occlusive disease) and decreased mortality. The
 HAS notes, however, that HbA1c as a criterion for substituting morbidity and mortality
 endpoints in type 2 diabetes is not sufficiently supported in the scientific literature.

 Be that as it may, HAS recommends individualizing the goal of glycemic control according to
 the profile of the patient and in particular to mobilize the recommended therapeutic means to
 reach the HbA1c target, in particular the dietary and hygiene measures. The data in the
 literature do not allow to define a lower limit for the HbA1c target. For most type 2
 diabetic patients, an HbA1c target of less than or equal to 7% is recommended.

 A target of 6.5% is recommended for newly diagnosed patients with no history of
 cardiovascular disease and a life expectancy of more than 15 years, as well as for women
 during pregnancy. An HbA1c target of 8% or less is recommended for patients with proven
 severe comorbidity and / or limited life expectancy (<5 years), or with advanced or
 long-lasting macrovascular complications diabetes (> 10 years) and for whom the target of 7%
 is difficult to achieve because drug intensification causes severe hypoglycaemia, or with a
 history of macrovascular complication considered as advanced, or with severe chronic renal
 insufficiency or (stages 4 and 5), as well as for the so-called frail elderly. For elderly
 people who are "sick", the priority is to avoid acute complications due to diabetes
 (dehydration, hyperosmolar coma) and hypoglycaemia; Pre-meal capillary glucose values of
 between 1 and 2 g / l and / or an HbA1c level of less than 9% are recommended. There are many
 molecules available on the pharmaceutical market to treat this disease (biguanides,
 hypoglycemic sulfonamides, DPP-4 inhibitors, GLP-1 analogues, alpha-glucosidase inhibitors,
 insulin, etc.). It is important to choose, depending on the clinical profile of the patient,
 the molecule (s) to be combined in order to achieve the glycated hemoglobin targets set by
 health organizations.
In recent years, many medical decision support software (diagnostic or therapeutic) have
 emerged to help doctors in their choices. For type 2 diabetes, apart from a decision-making
 aid tool posted on the HAS website, the Diascope tool can be cited. A group of 12 European
 experts came together to create this software to help doctors when diabetic patients do not
 reach their goal. They worked on more than 2000 clinical scenarios and thus established
 therapeutic recommendations. They prioritized the recommendations in 3 levels. For each
 patient profile, the most appropriate therapeutic proposals appear in green, inappropriate
 options appear in red, and acceptable but uncertain options appear in yellow.

 These two tools can help optimize patient management by finding the therapeutic strategy that
 is closest to the recommendations that are adapted to each patient.

 Therapeutic education, which has a key role in the care of these patients, has a demonstrated
 impact on quality improvement. In this prospective study, the authors also found a link
 between improved quality of life and lower HbA1c. This study uses the Diabetes Quality of
 Life (DQOL) score. A more appropriate score allowing a customization of the elements
 constituting the quality of life is the Audit of Diabetes-Dependent Quality of Life score
 (ADDQOL score).

 Physical activity is recommended for multiple reasons in Health. The summary of Inserm's
 collective expertise perfectly summarizes the benefits and the modalities of a physical
 activity for Health.

 There are clear international recommendations on the subject of moderate physical activity of
 at least 150 minutes per week, for example on the World Health Organization website or in the
 text of the recommendations of the American College of Sport Medicine and the American Heart
 Association. Adaptations of these recommendations for older people are also available.
 Walking and cycling are the two physical activities most cited in these documents because of
 their progressive and mild characteristics particularly suitable for patients with
 rheumatological indications and / or significant overweight. However, the practice of cycling
 can, depending on the natural terrain, involve efforts and pressures in joints and
 musculotendinous too important.

 This will often be the case in the natural environment of the most often hilly spas. In
 addition, there are many practical or psychological obstacles to cycling in a population of
 patients suffering from chronic pathologies: "it's too hard", "I do not know how to do it
 anymore", "it's for young people "," I am less strong than the others so I can not accompany
 them in their outings ".... The electric assistance bicycle (EVA) can then be useful. A very
 comprehensive report from the DGS (Direction Générale de la Santé : General Health Direction)
 of the Canton of Geneva takes stock of the positive impact of the dissemination of routine
 use of VAE (Available on http://www.impactsante.ch/pdf/EIS_VAE_2006.pdf). Still in
 Switzerland, J Welker, despite a provocative title, concludes that "The electric-assisted
 bicycle (EVA) is a physical activity in its own right and represents a means to fight
 sedentariness". These authors suggest from a study conducted in Lausanne that VAE even with a
 high attendance represents a real physical activity (> 6 MET) on hilly paths.

 It has been shown on small series with real-time measurements of the effort that the VAE with
 strong attendance was equivalent to a brisk walk and that the VAE with moderate assistance
 was intermediate in terms of physical effort between brisk walking and cycling without. It
 has also been shown that the use of VAE can achieve the objectives recommended for the
 practice of physical activity.

 The hydrotherapy has demonstrated its effectiveness especially for indications rheumatology
 and for the management of obesity (indication metabolic diseases). The benefit of the
 multifaceted actions implemented during a spa treatment concerns the symptoms, the reduction
 of pain and / or weight loss. As a result, randomized controlled trials have shown a benefit
 on quality of life.

 Metabolic disorders and especially diabetes and overweight are an indication of thermal
 cures. Two studies have shown positive results of a thermal cure on metabolic disorders. The
 first is a multicentre study in overweight or obese subjects (8% of whom are diabetic) who
 has demonstrated a significant benefit on weight and body mass index (BMI) of a spa treatment
 and the maintenance of this condition. improvement one year later compared to a control
 group. The second is a monocentric study in which a disappearance of a metabolic syndrome was
 observed one year after a spa treatment for 50% of patients included and 76% of patients
 followed at one year. Finally, an improvement in weight, BMI and fasting blood glucose at the
 end of a spa treatment was found in a preliminary study in 21 subjects with type 2 diabetes,
 with a decrease of 0.5% in glycated hemoglobin (HbA1c) 3 months after the beginning of the
 treatment.

 These positive data on parameters strongly correlated with diabetes (weight, BMI, metabolic
 syndrome), and on the glycemic parameters of a preliminary study with a small number of
 diabetic patients justify the completion of a multicenter study to evaluate the benefit to a
 patient. year of a 3 weeks spa treatment in the type 2 diabetic patient.
Inclusion Criteria:

 1. Patient with type 2 diabetes defined by (HAS 2013):

 -  a blood glucose level above 1.26 g / l (7.0 mmol / l) after an 8-hour fast and
 checked twice;

 -  or the presence of symptoms of diabetes (polyuria, polydipsia, weight loss)
 associated with blood glucose (on venous plasma) greater than or equal to 2 g / l
 (11.1 mmol / l);

 -  or blood glucose (on venous plasma) greater than or equal to 2 g / l (11.1 mmol /
 l) 2 hours after an oral load of 75 g of glucose (criteria proposed by the World
 Health Organization).

 2. Patient with HbA1c at inclusion> 7 and <12% (on an HbA1c dose less than 6 months old
 at the prescreening)

 3. Patient with a BMI ≥ 25 and a weight ≤ 125 kg

 4. Patient with appropriate treatment

 5. Age ≥ 18 years

 6. Available to go on treatment in 6 weeks after inclusion

 7. Available for a 12-month follow-up

 8. Affiliated to the social security or beneficiary of such a scheme

 Exclusion Criteria:

 1. Diabetes type 1 or secondary

 2. Patient with GFR (glomerular filtration rate) <50 ml / min (MDRD formulation) for at
 least 1 year.

 3. Unstable diabetes defined by the knowledge of the questioning of a change in HbA1c of
 +/- 1 in the last 6 months.

 4. With known serious comorbidity and / or limited life expectancy (<5 years), or with
 advanced macrovascular complications: in particular cardiovascular (acute coronary
 diseases and / or stroke in the last 6 months) and renal

 5. Severe psychiatric pathology or psychosis

 6. Pregnant woman, parturient or breastfeeding

 7. Contraindication to hydrotherapy

 8. Patient with a contraindication to moderate physical activity or cycling (acute
 coronary artery disease less than 2 years old, musculoskeletal problem of the spine or
 lower limbs incompatible with cycling).

 9. No previous spa treatment for "Digestive disorders and metabolic diseases" in the
 current the spa year.

 10. Person deprived of liberty or legal protection measure

 11. Subject participating to an other clinical study interventional.