Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. (DIABEO2THERMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912623
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
TIMC-IMAG
Floralis
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: 3 weeks SPA Treatment

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
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. Quantitative evolution of HbA1c [ Time Frame: 12 months ]
    HbA1C at 12 months in quantitative value adjusted to the value at inclusion

  3. 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.


  4. 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).


  5. 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.

  6. Biological parameters evolution [ Time Frame: 6 and 12 months ]
    Evolution of biological parameters

  7. Overweight evolution BMI [ Time Frame: 6 and 12 months ]
    Evolution of overweight (BMI)

  8. Overweight evolution abdominal perimeter [ Time Frame: 6 and 12 months ]
    Evolution of overweight (abdominal perimeter)

  9. 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).

  10. 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


  11. 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.

  12. 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


  13. Treatment compliance [ Time Frame: 6 months ]
    Evaluate the participation in thermal treatment, education and physical activity

  14. Therapeutic objectives evaluation [ Time Frame: 3 and 6 months ]
    Evaluation of the achievement of educational objectives of health behaviors by intermediate telephone follow-up.

  15. 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

  16. Subgroup analysis [ Time Frame: 6 months ]
    Sub group analysis on the primary outcome measure (stratification on primo spa therapy and age (median 62 years)).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Thermal cure in the current thermal season
  10. Person deprived of liberty or legal protection measure

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: CAROLE ROLLAND 33 4 76 76 50 40 carole.rolland@univ-grenoble-alpes.fr
Contact: CLAIRE EYCHENNE 33 4 76 76 09 89 claire.eychenne@univ-grenoble-alpes.fr

Locations
Layout table for location information
France
ROUSSEL Ludivine Not yet recruiting
Amiens, France
SOUDET Simon Not yet recruiting
Amiens, France
CLERGEOT Annie Not yet recruiting
Besançon, France
WATERLOT Not yet recruiting
Chambéry, France
PRUILHERE Sylvie Not yet recruiting
Clermont-Ferrand, France
DEBURGE Anne Not yet recruiting
Corbeil-Essonnes, France
PENFORNIS Alfred Not yet recruiting
Corbeil-Essonnes, France
BOREL Anne-Laure Not yet recruiting
Grenoble, France
PARADIS Sabrina Not yet recruiting
Montmélian, France
POPELIER Marc Not yet recruiting
Paris, France
APRILE Sophie Not yet recruiting
Vals-les-Bains, France
SAID Hatem Not yet recruiting
Vals-les-Bains, France
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
TIMC-IMAG
Floralis

Publications:

Layout table for additonal information
Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT03912623     History of Changes
Other Study ID Numbers: 2019-A00603-54
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Francaise pour la Recherche Thermale:
HbA1c
Diabetes
Type 2