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

NCT03912623 | Unknown

• 1 other identifier: 2019-A00603-54
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

HbA1c; Diabetes; Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Qualitative evolution of HbA1c

  6 months

• Quantitative evolution of HbA1c

  12 months

• Evaluation of the specific quality of life: (ADDQOL)

  6 and 12 months

• Evaluation of the overall quality of life: (EQ5D- 3L)

  6 and 12 months

• Medical care assessment

  6 and 12 months

Study Arms (2)

3 weeks SPA Treatment

ACTIVE COMPARATOR

3-week thermal cure: * Spa treatment harmonized in the different stations * Therapeutic education workshops and conferences common to all stations in the form of practical workshops during supervised lunches * Adapted physical activity, workshops are common to all spas and use an electric bike suitable for health (VELIS) with briefing and debriefing. An APA (Adapted Physical Activity) coaching consultation at the end of the cure for personalized post-cure programs and objectives is planned as well as a telephone or internet coaching during the 5 months post-cure (objectives and adaptation, motivation) * Maintenance of the usual treatment within 6 months post randomization with optimization of the therapeutic target in HbA1c and therapeutic strategies by the software Diascope and / or HAS * Information booklet for inclusion (French Association of Diabetics)

Other: SPA Treatment with therapeutic education and physical activity

Discovery week end

SHAM COMPARATOR

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

Interventions

SPA Treatment with therapeutic education and physical activity OTHER

3 weeks SPA Treatment plus therapeutic education plus physical activity

3 weeks SPA Treatment

Week end OTHER

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

Discovery week end

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patient with a BMI ≥ 25 and a weight ≤ 125 kg
• Patient with appropriate treatment
• Age ≥ 18 years
• Available for a 12-month follow-up
• Affiliated to the social security or beneficiary of such a scheme

You may not qualify if:

• Diabetes type 1 or secondary
• Patient with GFR (glomerular filtration rate) \<50 ml / min (MDRD formulation) for at least 1 year.
• Unstable diabetes defined by the knowledge of the questioning of a change in HbA1c of +/- 1 in the last 6 months.
• 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
• Severe psychiatric pathology or psychosis
• Pregnant woman, parturient or breastfeeding
• Contraindication to hydrotherapy
• 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).
• No previous spa treatment for "Digestive disorders and metabolic diseases" in the current the spa year.
• Person deprived of liberty or legal protection measure
• Subject participating to an other clinical study interventional.

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• TIMC-IMAG: collaborator
• Floralis: collaborator

Study Sites (9)

ROUSSEL Ludivine

Amiens, France

NOT YET RECRUITING

SOUDET Simon

Amiens, France

NOT YET RECRUITING

ODDOU Christel

Annecy, France

NOT YET RECRUITING

CLERGEOT Annie

Besançon, France

NOT YET RECRUITING

WATERLOT

Chambéry, France

NOT YET RECRUITING

DAOUDI

Corbeil-Essonnes, France

NOT YET RECRUITING

PENFORNIS Alfred

Corbeil-Essonnes, France

NOT YET RECRUITING

BETRY Cécile

Grenoble, France

NOT YET RECRUITING

PARADIS Sabrina

Montmélian, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 21705069 BACKGROUND

• Ampudia-Blasco FJ, Benhamou PY, Charpentier G, Consoli A, Diamant M, Gallwitz B, Khunti K, Mathieu C, Ridderstrale M, Seufert J, Tack C, Vilsboll 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.

  PMID: 25347226 BACKGROUND

• 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.

  PMID: 18829362 BACKGROUND

• 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. doi: 10.1023/a:1026485130100.

  PMID: 10457741 BACKGROUND

• Forestier R, Desfour H, Tessier JM, Francon 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.

  PMID: 19734131 BACKGROUND

• 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.

  PMID: 23346190 BACKGROUND

• 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.

  PMID: 23886461 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

CAROLE ROLLAND

CONTACT

33 4 76 76 50 40; carole.rolland@univ-grenoble-alpes.fr

CLAIRE EYCHENNE

CONTACT

33 4 76 76 09 89; claire.eychenne@univ-grenoble-alpes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Controlled, Randomized, Open Group Therapeutic Trial

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: September 13, 2019
• Primary Completion: March 1, 2022
• Study Completion: February 1, 2024
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)