Diabetes Mellitus Clinical Trial
Official title:
Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. Multicenter Randomized Therapeutic Trial
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.
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