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

Diabetes Mellitus Clinical Trial

— DIABEO2THERMES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03912623
• Other study ID #: 2019-A00603-54
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2020
• Source: Association Francaise pour la Recherche Thermale
• Contact: CAROLE ROLLAND
• Phone: 33 4 76 76 50 40
• Email: carole.rolland[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• SPA Treatment with therapeutic education and physical activity
3 weeks SPA Treatment plus therapeutic education plus physical activity
• Week end
access to the station for a week end after maintenance of usual treatment during 6 months

Locations

Country	Name	City	State
France	ROUSSEL Ludivine	Amiens
France	SOUDET Simon	Amiens
France	ODDOU Christel	Annecy
France	CLERGEOT Annie	Besançon
France	WATERLOT	Chambéry
France	DAOUDI	Corbeil-Essonnes
France	PENFORNIS Alfred	Corbeil-Essonnes
France	BETRY Cécile	Grenoble
France	PARADIS Sabrina	Montmélian

Sponsors (3)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	Floralis, TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (7)

Ampudia-Blasco FJ, Benhamou PY, Charpentier G, Consoli A, Diamant M, Gallwitz B, Khunti K, Mathieu C, Ridderstråle M, Seufert J, Tack C, Vilsbøll T, Phan TM, Stoevelaar H. A decision support tool for appropriate glucose-lowering therapy in patients with type 2 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):194-202. doi: 10.1089/dia.2014.0260. Epub 2014 Oct 27. — View Citation

Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91. — View Citation

Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, Lin JK, Farzadfar F, Khang YH, Stevens GA, Rao M, Ali MK, Riley LM, Robinson CA, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet. 2011 Jul 2;378(9785):31-40. doi: 10.1016/S0140-6736(11)60679-X. Epub 2011 Jun 24. Review. — View Citation

Debaty I, Halimi S, Quesada JL, Baudrant M, Allenet B, Benhamou PY. A prospective study of quality of life in 77 type 1 diabetic patients 12 months after a hospital therapeutic educational programme. Diabetes Metab. 2008 Nov;34(5):507-13. doi: 10.1016/j.diabet.2008.03.007. Epub 2008 Sep 30. — View Citation

Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3. — View Citation

Gin H, Demeaux JL, Grelaud A, Grolleau A, Droz-Perroteau C, Robinson P, Lassalle R, Abouelfath A, Boisseau M, Toussaint C, Moore N. Observation of the long-term effects of lifestyle intervention during balneotherapy in metabolic syndrome. Therapie. 2013 May-Jun;68(3):163-7. doi: 10.2515/therapie/2013025. Epub 2013 Jul 26. — View Citation

Hanh T, Serog P, Fauconnier J, Batailler P, Mercier F, Roques CF, Blin P. One-year effectiveness of a 3-week balneotherapy program for the treatment of overweight or obesity. Evid Based Complement Alternat Med. 2012;2012:150839. doi: 10.1155/2012/150839. Epub 2012 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c evolution	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).	6 months
Secondary	Qualitative evolution of HbA1c	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	6 months
Secondary	Quantitative evolution of HbA1c	HbA1C at 12 months in quantitative value adjusted to the value at inclusion	12 months
Secondary	Evaluation of the specific quality of life: (ADDQOL)	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.	6 and 12 months
Secondary	Evaluation of the overall quality of life: (EQ5D- 3L)	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).	6 and 12 months
Secondary	Medical care assessment	evaluation of the medical care of patients (treatments, paramedical procedures, hospitalizations ...), comparison between the 2 groups of treatment modifications.	6 and 12 months
Secondary	Biological parameters evolution	Evolution of biological parameters	6 and 12 months
Secondary	Overweight evolution BMI	Evolution of overweight (BMI)	6 and 12 months
Secondary	Overweight evolution abdominal perimeter	Evolution of overweight (abdominal perimeter)	6 and 12 months
Secondary	Clinical repercussions evolution	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).	6 and 12 months
Secondary	Physical activity measurement : (GPAQ score)	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	6 and 12 months
Secondary	Physical performance measurement	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.	During SPA therapy
Secondary	Self-esteem (Rosenberg score) assessment	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	6 and 12 months
Secondary	Treatment compliance	Evaluate the participation in thermal treatment, education and physical activity	6 months
Secondary	Therapeutic objectives evaluation	Evaluation of the achievement of educational objectives of health behaviors by intermediate telephone follow-up.	3 and 6 months
Secondary	Side effects evaluation	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	6 and 12 months
Secondary	Subgroup analysis	Sub group analysis on the primary outcome measure (stratification on primo spa therapy and age (median 62 years)).	6 months