Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. (DIABEO2THERMES)
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|ClinicalTrials.gov Identifier: NCT03912623|
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Physical Activity Dietetic Rules Therapeutic Education||Other: SPA Treatment with therapeutic education and physical activity Other: Week end||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter, Controlled, Randomized, Open Group Therapeutic Trial|
|Masking:||None (Open Label)|
|Masking Description:||We wil use the zelen randomisation to minimize patient disappointment. The patient will be advice of only one group (3 weeks SPA treatment or only a week end access to the SPA)|
|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|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||February 1, 2023|
Active Comparator: 3 weeks SPA Treatment
3-week thermal cure:
Other: SPA Treatment with therapeutic education and physical activity
3 weeks SPA Treatment plus therapeutic education plus physical activity
Sham Comparator: Discovery week end
Maintenance of usual treatment within 6 months post-randomization with optimization of the therapeutic target in HbA1c and therapeutic strategies by Diascope and HAS software In addition, a "discovery" access to the baths of 2-3 days will be offered to patients. Finally, the information booklet on diabetes will be given at the inclusion (French Federation of Diabetics).
Other: Week end
access to the station for a week end after maintenance of usual treatment during 6 months
- HbA1c evolution [ Time Frame: 6 months ]Difference in mean HbA1c between the intervention group (spa treatment) at 6 months post start of treatment and the reference group (usual care) at 6 months post randomization taking into account (Ancova) the last value of d HbA1c available (at baseline or at baseline).
- Qualitative evolution of HbA1c [ Time Frame: 6 months ]Success defined by three criteria for the evolution of HbA1c: percentage of patients with HbA1c less than or equal to 7% (HAS Criterion) or percentage of patients with at least 1% reduction in HbA1c or percentage of patients who achieved the target HbA1c defined at inclusion
- Quantitative evolution of HbA1c [ Time Frame: 12 months ]HbA1C at 12 months in quantitative value adjusted to the value at inclusion
- Evaluation of the specific quality of life: (ADDQOL) [ Time Frame: 6 and 12 months ]
The ADDQOL (Audit of Diabetes-Dependent Quality of Life Scale) contain 19 domains.
These 19 domains ask the respondents to evaluate how their life would be if they did not have diabetes. The scales range from −3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from −9 to +3). Lower scores reflect poorer QoL. Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains.
- Evaluation of the overall quality of life: (EQ5D- 3L) [ Time Frame: 6 and 12 months ]
Euroquol 5D (EQ5D- 3L) quality of life scale. Euroquol 5D (EQ5D- 3L) quality of life scale. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D-3L contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Each dimension has 3 levels (no problem, some problem, extreme problem).
- Medical care assessment [ Time Frame: 6 and 12 months ]evaluation of the medical care of patients (treatments, paramedical procedures, hospitalizations ...), comparison between the 2 groups of treatment modifications.
- Biological parameters evolution [ Time Frame: 6 and 12 months ]Evolution of biological parameters
- Overweight evolution BMI [ Time Frame: 6 and 12 months ]Evolution of overweight (BMI)
- Overweight evolution abdominal perimeter [ Time Frame: 6 and 12 months ]Evolution of overweight (abdominal perimeter)
- Clinical repercussions evolution [ Time Frame: 6 and 12 months ]Evolution at 6 months and 12 months of the clinical repercussions of diabetes (collection of declarative SAEs with validation by a committee). Analysis of hospitalizations related to diabetes (macro and microvascular repercussions, metabolic complications, severe hypoglycaemia).
- Physical activity measurement : (GPAQ score) [ Time Frame: 6 and 12 months ]
Measurement of physical activity at 6 and 12 months with Global Physical Activity Questionnaire (GPAQ score).The Global Questionnaire on Physical Exercise (GPAQ), has 16 questions.
The score obtained makes it possible to establish three profiles: insufficient level of physical activity, level according to the recommendations, high level
- Physical performance measurement [ Time Frame: During SPA therapy ]Pre and post cure measurement of physical performance. Evolution of performances during bike rides (VELIS). Profile of the parameters recorded on the VELIS (cardio, speed, electric power supplied by the engine, pressure on the pedals) at the beginning and end of treatment on the same reference course.
- Self-esteem (Rosenberg score) assessment [ Time Frame: 6 and 12 months ]
Assessment of self-esteem building with the Rosenberg score.The Rosenberg score is between 10 and 40.
The interpretation of the results is identical for a man or a woman. score below 25, self-esteem is very low. score between 25 and 31, self-esteem is low. score between 31 and 34, self-esteem is average. score between 34 and 39, self-esteem is strong. score above 39, self-esteem is very strong
- Treatment compliance [ Time Frame: 6 months ]Evaluate the participation in thermal treatment, education and physical activity
- Therapeutic objectives evaluation [ Time Frame: 3 and 6 months ]Evaluation of the achievement of educational objectives of health behaviors by intermediate telephone follow-up.
- Side effects evaluation [ Time Frame: 6 and 12 months ]Evaluation of the side effects of the thermal treatment (SAE reporting). Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials
- Subgroup analysis [ Time Frame: 6 months ]Sub group analysis on the primary outcome measure (stratification on primo spa therapy and age (median 62 years)).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912623
|Contact: CAROLE ROLLAND||33 4 76 76 50 firstname.lastname@example.org|
|Contact: CLAIRE EYCHENNE||33 4 76 76 09 email@example.com|
|ROUSSEL Ludivine||Not yet recruiting|
|SOUDET Simon||Not yet recruiting|
|CLERGEOT Annie||Not yet recruiting|
|WATERLOT||Not yet recruiting|
|PRUILHERE Sylvie||Not yet recruiting|
|DEBURGE Anne||Not yet recruiting|
|PENFORNIS Alfred||Not yet recruiting|
|BOREL Anne-Laure||Not yet recruiting|
|PARADIS Sabrina||Not yet recruiting|
|POPELIER Marc||Not yet recruiting|
|APRILE Sophie||Not yet recruiting|
|SAID Hatem||Not yet recruiting|