Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient.

Summary

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.

Conditions

• Diabetes Mellitus
• Physical Activity
• Dietetic Rules
• Therapeutic Education

Interventions

OTHER

SPA Treatment with therapeutic education and physical activity

3 weeks SPA Treatment plus therapeutic education plus physical activity

OTHER

Week end

access to the station for a week end after maintenance of usual treatment during 6 months

Sponsors & Collaborators

• TIMC-IMAG

  collaborator OTHER

• Floralis

  collaborator INDUSTRY

• Association Francaise pour la Recherche Thermale

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-13

Primary Completion

2022-03-01

Completion

2024-02-01

Countries

• France

Study Locations